Указ-закон № 59/2006 от 26.12.2006 г. «О лекарственных препаратах», Кабо-Верде

Decree­Law No. 59/2006

of December 26

Medicinal products are vital in terms of health, the economy and society as a whole.

Therefore, there is an acute need for up­to­date regulations on pharmaceutical activities.

More than 12 years after the introduction of the regulations contained in Decree­Law

3/93, of February 15, steps must be taken, as a matter of urgency, to update these rules

and address their inherent inconsistencies and shortcomings, which prevent them from

being fully implemented. The aim must be to modernize and update the entire legal

framework governing medicinal products, from manufacture to marketing, always

bearing in mind the need for and importance of evaluation and inspection activity,

fundamental in ensuring the quality, safety and efficacy of medicinal products and for the

protection of public health.

The aim of the present decree is, therefore, to establish more comprehensive and

complete rules with regard to issues linked to the authorization of the marketing,

registration, manufacture, importation, exportation, marketing, donation and advertising

of medicinal products for human use.

Thus,

By way of the power afforded by Article 203 (2) (a) of the Constitution, the Government

decrees the following:

CHAPTER 1

Aim, scope and definitions

Article 1

Aim

The present Decree shall govern the authorization of the marketing, registration,

manufacture, importation, exportation, sale, donation, and advertising of medicinal

products for human use.

Article 2

Scope

1. The present Decree shall apply to medicinal products for human use intended

to be placed on the market in the form of generic drugs or proprietary

medicinal products.

2. Medicinal products derived from human blood or plasma, immunological,

radiopharmaceutical, homeopathic and herbal medicinal products, as well as

those which may contain narcotic drugs and psychotropic substances shall be

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subject to the provisions of this Decree, without prejudice to the provisions of

special legislation.

Article 3

Definitions

For the purposes of the present Decree, the following definitions shall apply:

(a) Medicinal product: Any substance or association of substances presented as

having curative or preventive properties with regard to human diseases or their

symptoms, or which may be used or administered to human beings with a view to

achieving a clinical diagnosis or, by performing a pharmacological,

immunological or metabolic action, restore, correct or modify physiological

functions;

(b) Proprietary medicinal products: Any ready­prepared medicinal product placed

on the market under a special name and in an appropriate pack;

(c) Officinal formula: Any medicinal product which is prepared in accordance with

the prescriptions of a pharmacopeia or an official formulary, in a dispensing

pharmacy or in a hospital pharmacy service, to be supplied to a specific patient by

that pharmacy or service;

(d) Magistral formula: Any medicinal product prepared extemporaneously in a

dispensing pharmacy or hospital pharmacy service, in accordance with a medical

prescription written by a doctor registered with the Doctors’ Association, intended

for a specific patient;

(e) Essentially similar medicinal products: Any medicinal products having the same

qualitative and quantitative composition in terms of active principles and the same

pharmaceutical form and which, where necessary, have been shown to be

bioequivalent with the reference medicinal product, based on appropriate

bioavailability studies;

(f) Reference medicinal product: A medicinal product whose active substance has

been authorized on the basis of complete documentation, including results of pre­

clinical and clinical pharmaceutical tests;

(g) International Nonproprietary Name (INN): Designation adopted or proposed at

the international level, under the aegis of the World Health Organization (WHO)

and in accordance with established procedures, for active substances of medicinal

products, which cannot be registered as a trademark or name, in accordance with

the list published by that Organization on a periodical basis.

(h) Generic name: Designation by which the active substance of a medicinal product

is known, which does not correspond to an approved or recommended INN and is

not registered as a trademark or name;

(i) Generic medicinal product (MG): A generic medicinal product shall be

designated by its INN or, in the absence of an INN, its generic name, followed by

the strength, the pharmaceutical form and the initials MG, which must be marked

on the outer packaging of the medicinal product. The generic medicinal products

must meet all the following conditions:

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i. It must be essentially similar to a reference medicinal product already

on the market and the respective active substances must be

manufactured through processes that have fallen into the public

domain or are protected by a patent held by the applicant or

manufacturer or exploited with the authorization of the respective

holder; and

ii. Claims should not be made regarding therapeutic indications different

to those of the reference medicinal product.

(j) Active substance: Any material of human, animal, plant or chemical origin, to

which is attributed an activity appropriate for a medicinal product;

(k) Pharmaceutical form: Final state of active substances following subjection to the

necessary pharmaceutical operations, in order to facilitate their determination and

achieve the maximum desired therapeutic effect;

(l) Product name: Designation of the medicinal product, which may consist of a

trademark incapable of being confused with the INN, the INN accompanied by a

trademark, or the name of the applicant or holder of the authorization, provided

that no misunderstandings arise with regard to the therapeutic properties and

nature of the medicinal product;

(m)Strength: Content of active substance expressed quantitatively per dosage unit,

per unit of volume or weight according to the dosage form;

(n) Presentation: Dimension of the packaging taking into account the number of

units;

(o) Immediate packaging: The container or other form of packaging immediately in

contact with the medicinal product;

(p) Outer packaging: The packaging into which is placed the immediate packaging;

(q) Labeling: Information on the immediate or outer packaging;

(r) Package leaflet: written information intended for the user which accompanies the

medicinal product;

(s) Medicinal product for hospital use: Medicinal product which, in accordance with

the respective marketing authorization or national list of approved medicinal

products and owing to its pharmacology, level of innovation, and on public health

grounds, is exclusively reserved for use in hospitals;

(t) Wholesale marketing of medicinal products for human use: Commercial activity

consisting in procuring, holding, storing or supplying medicinal products to be

processed, resold or used by medical services, health units and pharmacies, apart

from directly supplying medicinal products to the public;

(u) Wholesale trade establishment engaged in the trade in medicinal products for

human use: Trade establishment whose main activity is the wholesale trade in

medicinal products for human use;

(v) Advertising of medicinal products: Any form of communication, information,

canvassing or incentive which directly or indirectly encourages the prescription,

dispensing, sale, acquisition or consumption of medicinal products;

(w)Raw material: Any substance, active or inactive, regardless of origin, used in the

manufacture of a medicinal product, which either remains unaltered, changes or

disappears during the course of the process;

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(x) Excipient: Any raw material which, including in its pharmaceutical forms, is

added to active substances or their associates to serve as a carrier, enable those

active substances or their associates to be prepared and stabilized, modify their

organoleptic properties, or determine the physico­chemical properties of the

medicinal product and its bioavailability;

(y) Pharmaceutical quality assurance: The total sum of the organized arrangements

made with the object of ensuring that medicinal products are of the quality

required for their intended use;

(z) Good manufacturing practice: The part of quality assurance designed to ensure

that products are consistently produced and controlled in accordance with the

quality standards appropriate to their intended use;

(aa) Donations: Offers or gifts of medicinal products made by foreign bodies

or institutions to the public health structures, religious organizations and public­

interest associations;

(bb) Adverse reaction: A reaction to a medicinal product which is noxious and

unintended and which occurs at doses normally used in humans for the

prophylaxis, diagnosis or treatment of disease or the recovery, correction or

modification of physiological function;

(cc) Serious adverse reaction: An adverse reaction which results in death, is

life­threatening, requires hospitalization or the extension of the period of

hospitalization, results in significant disability or incapacity, is a congenital

anomaly/birth defect;

(dd) Unexpected adverse reaction: An adverse reaction, the nature, severity,

intensity or outcome of which is not consistent with the summary of the product

characteristics;

(ee) Periodic safety report: The periodic and updated communication of safety

information available at the international level regarding each medicinal product,

accompanied by a scientific evaluation of the risks and benefits afforded by the

medicinal product;

(ff) Post­marketing surveillance studies: Pharmacoepidemiological study or a clinical

trial carried out in accordance with the terms of the authorization, conducted with

the aim of identifying and investigating a safety hazard relating to an authorized

medicinal product;

(gg) Abuse of medicinal products: Persistent or sporadic, intentional excessive

use of medicinal products which is accompanied by harmful physical or

psychological effects;

(hh) Risk­benefit evaluation: The evaluation of the positive therapeutic effects

of a medicinal product in relation to the risks with regard to patient or public

health and the safety, quality and efficacy of the medicinal product;

(ii) Urgent safety restriction: An interim change to information on the authorized

medicinal product affecting the safety information included in the summary of the

characteristics of the medicinal product, notably indications, posology, contra­

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indications, warnings and adverse reactions, in light of new information

concerning the safe use of the product;

(jj) Immunological medicinal products: Vaccines, toxins and serums, including, in

particular, any product administered to produce active or passive immunity, as

well as any product intended to diagnose, induce or reduce a specific

hypersensitivity in the immunological response to an allergen agent;

(kk) Radiopharmaceutical product: Any medicinal product which, when ready

for use, contains one or more radionuclides or radioactive isotopes included for a

therapeutic purpose;

(ll) Medicinal products derived from human blood or human plasma: Medicinal

products based on blood constituents, in particular, albumin, concentrates of

coagulating factors and immunoglobulins of human origin;

(mm) Herbal medicinal product: Any medicinal product, exclusively containing

as active ingredients one or more herbal substances or one or more herbal

preparations, or one or more such herbal substances in combination with one or

more such herbal preparations

Chapter II

Procedure for marketing authorization

SECTION I

General Provisions

Article 4

Authorization

1. The placing on the market of any medication, manufactured in Cape Verde or

imported, requires the prior authorization of the General Directorate for

Pharmacy (DGF), granted once the views of the National Medicinal Products

Commission and the Agency for the Regulation and Supervision of

Pharmaceutical and Food Products (ARFA) have been heard.

2. When a medicinal product has been granted a marketing authorization, any

additional strengths, pharmaceutical forms, administration routes, additional

presentations, as well as any variations and extensions that are granted

authorization, shall be considered to be included in the marketing

authorization already granted.

3. Medicinal products imported in accordance with Article 44 shall be exempt

from the marketing authorization, the person responsible for their importation

providing the DGF, within 90 days of the request, with a minimum of

information on the medicinal product which must include the following

elements:

a. A copy of the approval in the country of origin, if any.

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b. Summary of product characteristics, package leaflet and packaging

approved in the country of origin; and

c. Details of the manufacturer and a copy of the certificate of good

manufacturing practice (GMP).

Article 5

Application

1. Marketing authorization shall be granted following an application by the

interested party, addressed to the Director General of Pharmacy, which must

contain the following elements:

a. Name and address of residence or head office of the applicant;

b. Name of technical director, the person responsible for the introduction of

the product onto the market and who certifies the authenticity and veracity

of the documents contained in the dossier;

c. Proposed name of medicinal product;

d. Pharmaceutical form and composition in terms of active substances,

excipients, including strength, presentation, administration route, posology

and shelf life;

e. Therapeutic indication(s) established by the results of the clinical studies

contained in the documents making up the dossier;

f. Number of volumes in the dossier.

2. The application referred to in the preceding paragraph must be accompanied

by the following documents;

a. National marketing authorization request form;

b. Summary of medicinal product characteristics which must be presented in

the Portuguese language;

c. Brief description of the manufacturing method and control tests employed

by the manufacturer;

d. Expert reports, referring to pre­clinical and clinical pharmaceutical tests,

which must be in the Portuguese language, and which must state that the

corresponding internationally recognized professional good practices were

observed when obtaining said results.

e. Environmental risk assessment report on the medicinal product,

accompanied, where possible, by the proposed risk limitation measures;

f. Draft label, packaging, outer packaging and package leaflet, which must

be in the Portuguese language.

g. Information sheet verifying the qualitative and quantitative composition of

the product in terms of the active ingredients;

h. Document demonstrating that the manufacturer is authorized to produce

the proprietary medicinal product in his country; and

i. Copies of the marketing authorizations of the medicinal product in other

countries, as well as of decisions refusing authorization, including the

respective grounds;

j. Document attesting to payment of fee charged for the service.

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3. The name of the medicinal product may be made up of an invented name or a

trademark, the INN or generic name followed by the name of the

manufacturer or brand.

4. In cases where the proposed product name is an invented name or a

trademark, the INN shall be clearly marked.

5. Invented names or trademarks must not be liable to confusion with INNs, nor

to create misunderstandings concerning the therapeutic properties and nature

of the medicinal product.

6. The application shall be signed jointly by the applicant and the Technical

Director.

7. Should the Technical Director also be the applicant, one signature shall be

sufficient.

8. During the evaluation process, the DGF may require samples of the medicinal

product in sufficient number to allow for the product to be analyzed, possibly

repeatedly.

Article 6

Additional elements and clarification

The DGF may request the applicant to provide any additional elements and clarification

considered necessary, failure to comply leading to the rejection of the application.

Article 7

Written information

1. The manufacturer, importer and/or distributor shall be responsible for the

inclusion of information written in the Portuguese language on the

characteristics and precautions to observe when using the medicinal product,

without prejudice to this information being simultaneously provided in other

languages.

2. The information referred to in the preceding paragraph must appear on the

immediate and outer packaging and on the package leaflet referred to in

Article 10 of this Decree, together with an explanation and details of the

authorization process.

3. The information to be included under paragraph 1 shall be subject to prior

verification by the DGF, in order to establish its veracity and suitability.

4. Alterations to labeling and package leaflets require the authorization of the

DGF.

5. In cases of non­compliance with the present Decree, the applicant or holder of

marketing authorization shall be notified in order to carry out the due

corrections, a time period being set for this purpose.

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6. Non­compliance with the provision contained in the preceding paragraph

within the time period set shall lead to the suspension of the marketing

authorization and consequent withdrawal from the market until the labeling

and/or package leaflet of the medicinal product in question are in accordance

with the provisions of the present Decree.

Article 8

Summary of product characteristics

1. The summary of product characteristics (referred to in Article 5 [2] [b]) shall

include the following information:

(a) The name of the medicinal product, followed by its strength and

pharmaceutical form;

(b) The pharmaco­therapeutic category;

(c) The qualitative and quantitative composition in terms of active substances

and excipients, knowledge of which is necessary for correct administration

of the medicinal product. The INNs recommended by the World Health

Organization (WHO), or, in the absence thereof, the common names or

chemical descriptions shall be used.

(d) Clinical particulars

i. therapeutic indications;

ii. contra­indications;

iii. undesirable effects, frequency and seriousness;

iv. special precautions for use;

v. use during pregnancy or lactation;

vi. interaction with other medicinal products and other forms of

interaction;

vii. posology and method of administration for adults and, where

necessary, for children;

viii. overdose, symptoms, emergency procedures, antidotes;

ix. effects on ability to drive and to use machines.

(e) Pharmacological properties

i. pharmacodynamic properties;

ii. pharmacokinetic properties;

iii. preclinical safety data.

(f) Pharmaceutical particulars

i. list of excipients;

ii. incompatibilities;

iii. shelf life, after reconstitution of the medicinal product or

when the immediate packaging is opened for the first time.

(g) Name and address of marketing authorization holder or applicant;

(h) Marketing authorization number(s);

(i) Date of first authorization or renewal of the authorization;

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(j) Date of revision of the summary of product characteristics; and

2. The summary of product characteristics shall be approved by the DGF and the

applicant notified of this approval in accordance with Article 13.

3. The summary of product characteristics shall be kept permanently up to date,

in accordance with the law, the marketing authorization holder presenting the

appropriate applications for changes accordingly, on his own initiative or

following a request by the DGF.

Article 9

Labels

1. The supply to the public of medicinal products wrapped in packaging which is

not labeled in accordance with the provisions of this Decree shall be

prohibited.

2. Outer packaging or, in the absence thereof, immediate packaging, must bear

the following information in legible and indelible characters:

a. the international non­proprietary name (INN);

b. the qualitative and quantitative composition of the active substances per

dosage unit, per unit of volume or weight determined according to the

form of administration, including reference to the INN, where an INN for

the medicinal product exists;

c. the pharmaceutical form, presentation and strength;

d. the method and route of administration;

e. the shelf life, including month and year;

f. the list of excipients, knowledge of which might be necessary for the

appropriate use of the medicinal product. In the case of injectable

products and topical and eye preparations, all excipients shall be indicated;

g. production batch number;

h. retail sale price;

i. the phrase “Keep out of the reach of children”;

j. name and address of residence or head office of the marketing

authorization holder, manufacturer or importer;

k. the printed phrases “Medicinal product subject to medical prescription”,

“to be applied under clinical supervision only” (as the case may be) must

appear in a clearly visible location;

l. the shelf life after reconstitution of the medicinal product or when the

immediate packaging is opened for the first time, where appropriate;

m. specific storage precautions, where appropriate;

n. special precautions for the destruction of unused products or residues

derived from the medicinal products, where appropriate;

o. the phrases “free sample” and “prohibited for sale to the public”, or other

similar, where appropriate; and

p. the phrase “external use”, printed on a red background, where appropriate;

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q. the product’s indication, in the case of medicinal products not subject to

medical prescription;

3. In the case of ampoules, the indications provided for in the preceding

paragraph must appear on the outer packaging, the inclusion of the following

information on the immediate packaging being sufficient;

a. name of the medicinal product;

b. strength;

c. method and route of administration;

d. shelf life; and

e. production batch number.

4. Packaging containing a unit dose on which it is not possible to mention all of

the elements referred to in the preceding paragraph must bear the name of the

medicinal product, strength and shelf life, with the information referred to in

paragraph 1 of this Article appearing on the outer packaging.

5. Should there be more than one strength of the same medicinal product, in the

same pharmaceutical form, the outer packaging shall point out the different

strengths.

Article 10

Package leaflet

1. The aim of the package leaflet (PL) shall be to provide the patient with

information concerning a specific medicinal product, with no reference being

made to any other product.

2. The package leaflet must be written in the Portuguese language, in terms

which are clear and legible for the patient, without prejudice to the

information being simultaneously provided in other languages.

3. The inclusion of the package leaflet referred to in Article 5(2)(f) of this

Decree in the packaging containing the medicinal product shall be

compulsory, unless the information contained in that leaflet appears on the

outer packaging or the immediate packaging.

4. As well as the information referred to in subparagraphs (a) to (d) and (g) of

Article 8 (1), the package leaflet shall contain:

a. average treatment time;

b. instructions on what to do should one or more doses fail to be

administered;

c. information on how to stop the treatment if its suspension leads to

discontinuation symptoms;

d. specific storage precautions for medicinal products and information on

visible signs of deterioration, should they exist;

e. warning to the user to inform his doctor or pharmacist of any adverse

affects detected which are not referred to in the package leaflet;

f. warning to the user to check the shelf life;

g. date of revision of PL.

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5. The package leaflet may contain signs or images explaining certain

information referred to in the preceding paragraph, as well as other

information compatible with the summary of product characteristics and

useful in terms of health education, excluding any kind of advertising.

Article 11

Laboratory checks

1. The DGF may require the person responsible for marketing to submit

samples of the products at various stages of production, or of the finished

product, to a recognized public or private laboratory for checks.

2. The DGF shall guarantee that the required checks will be carried out and the

corresponding results communicated to the applicant within 90 days of

receipt of the samples.

Article 12

Time periods

1. Marketing authorization shall be granted within a period of 180 days from the

date of the request and 90 days in the cases provided for in Article 24.

2. The time period shall be suspended whenever, the process having yet to be

completed, the applicant has been notified to correct any defects, or whenever

additional elements or clarification have been requested.

3. In exceptional cases, the time period provided for in paragraph one may be

extended for a period of 60 days, the applicant being informed accordingly

prior to the end of the first time period.

4. Once authorization has been granted, the applicant shall have a period of 12

months, extendable only once, in duly justified cases, to introduce the

medicinal product onto the market, after which time the authorization shall

expire.

Article 13

Notification

1. The DGF must notify the applicant of the decision concerning the marketing

authorization request, indicating, in the case of rejection, the respective

grounds.

2. In cases in which authorization is granted, the DGF shall send the applicant a

copy of the summary of product characteristics, package leaflet and labeling,

in the terms in which they were approved.

Article 14

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Registration of medicinal products

1. Granting of the marketing authorization request shall lead to the registration of the

medicinal product.

2. Only three similar medicinal products may be registered for each medicinal

product.

3. For public health reasons, the marketing authorization provided for by this

Decree may be subject to certain special conditions, in particular with regard

to the respective duration, compulsory nature of further tests, specific

prescription conditions, possible restriction to certain specialized areas such as

hospital use and special procedures for the communication of adverse

reactions.

Article 15

Grounds for rejection

1. Applications for marketing authorization which do not fulfill the requirements

and formalities contained in this Decree shall be rejected, in particular when:

a. the dossier was not dealt with in accordance with the provisions of this

Decree or contains mistakes;

b. the medicinal product is harmful in the normal conditions of use, an

evaluation having been carried out on the basis of information obtained

from pharmacovigilance centers, or of statistically significant information

concerning undesirable effects, which alters the risk­benefit balance;

c. the therapeutic effect of the medicinal product has not been sufficiently

proven;

d. the qualitative and quantitative composition of the medicinal product is

not the same as that declared;

e. the effectiveness of the medicinal product (cost/benefit) has not been

proven.

2. Appeals may be lodged in the case of rejections of applications for marketing

authorization, in accordance with the legal provisions.

Article 16

Period of validity of authorization

The period of validity of the marketing authorization shall be five years, renewable

for an indeterminate period, unless, for reasons of pharmacovigilance, it is decided to

limit the additional renewal period to five years.

Article 17

Renewal of authorization

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1. Requests for renewal must be presented by the interested parties up to 90 days

prior to the end of the authorization.

2. The request for renewal must describe the situation with regard to the

pharamacovigilance data and, where appropriate, must be accompanied by

additional up­to­date documentation which demonstrates that the medicinal

product previously authorized has been adapted to take into account technical and

scientific advances.

3. The documentation to be submitted shall include:

a. the request in written form;

b. the renewal form;

c. proof of payment of the fees referred to in Article 22;

d. marketing authorization in the country of origin or, in its absence,

equivalent authorization drafted in accordance with the WHO

certification system; and

e. Periodic Safety Report drafted in accordance with the international

guidelines and standards in force.

Article 18

Suspension and refusal of renewal

1. The DGF may suspend marketing authorization, or refuse its renewal, in one of

the following cases:

a. In any of the circumstances provided for in Article 15(1)(b)­(e);

b. The medicinal product presents a risk to public health;

c. The information provided in the dossier accompanying the request for

authorization is incorrect or contradicted by more recent information;

and

d. Non­compliance with the principles of good manufacturing practice.

2. The interested party shall be notified of the suspension and of the grounds for that

measure, as well as of the time period for correcting any defects, failure to do so

leading to the expiry of the marketing authorization.

3. The suspension and expiry of marketing authorization shall always lead to the

withdrawal from the market of the respective medicinal product, within a time

period established by the DGF, based on the grounds for suspension or expiry.

4. The marketing authorization holder shall be responsible for the withdrawal from

the market referred to in the preceding paragraph.

Article 19

New authorization

1. The following alterations concerning medicinal products that have already

been authorized shall require new authorization, to be granted within 120

days:

a. name of medicinal product;

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b. qualitative and/or quantitative composition of the active substances and

excipients;

c. summary of product characteristics;

d. pharmaceutical form;

e. shelf life;

f. packaging material;

g. package leaflet; and

h. presentation.

2. The applicant shall present particulars, confirmed by experts specializing in

the respective areas, supporting the application.

Article 20

Variations to the terms of a marketing authorization

The standards applicable to the procedure for requests for the variation of a marketing

authorization, as well as the typology of those variations, shall be the subject of an Order

of the Minister for Health.

Article 21

Confidentiality

The elements submitted for the preparation of dossiers referred to in the present Decree

shall be confidential. All officials with knowledge of such elements shall be bound by

secrecy.

Article 22

Fee

1. The marketing authorization request for each medicinal product shall be

subject to the payment of a fee, set by a joint Order of the Ministers for Health

and Finance.

2. The abovementioned fee shall be collected at the time of the submission of the

request, independently of whether the request is granted or not.

SECTION II

Special Provisions

Article 23

Marketing authorization of generic medicinal products

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Without prejudice to the provisions contained in Section I of this Chapter, marketing

authorization of generic medicinal products shall be subject to the following details:

a. identification by means of the INN of the active substances or, in the absence

thereof, the generic name, followed by the strength and pharmaceutical form;

b. waiving of submission of expert reports on pharmacological, toxicological and

clinical tests; and

c. compulsory requirement to prove bioequivalence based on bioavailability

studies or, should they prove to be inadequate, proof of therapeutic

equivalence through appropriate clinical pharmacological studies.

Article 24

Recognition of marketing authorization granted by other States

1. The preparation of marketing authorization dossiers may be carried out through

the recognition of a marketing authorization granted by another State.

2. The recognition of the abovementioned marketing authorization shall only be

granted on the condition that the State which granted the authorization respects

the following conditions:

a. It has an official authority (service of the Ministry of Health of that

State or a specialized service, such as an “agency” or “institute”)

which evaluates and authorizes medicinal products, observing, for this

purpose, procedures, rules and standards recognized as components of

an organization which guarantees the quality of the medicinal products

introduced onto the market of the State in question; and

b. It guarantees, through its inspection services, that the internationally

recognized good manufacturing practices are effectively observed by

the manufacturers.

3. Marketing authorization requests based on the recognition of a marketing

authorization granted by another State, which meets the requirements contained in

paragraph 2, may be submitted by the respective holder, through an application

complying with the provisions of Article 5 (1).

4. Requests for recognition of marketing authorization must be accompanied by:

a. a copy of the initial authorization and, should the State which granted

the said authorization not be a Portuguese­speaking country, a

Portuguese­language translation, duly authenticated by the competent

authority;

b. a copy of the last summary of product characteristics, approved in the

country of origin and in the Portuguese language;

c. should additions or alterations have been made to the original (such as,

for example, new therapeutic indications, new undesirable effects,

modification of posologies or of method of administration), the

applicant shall make the corresponding declarations;

d. declaration by the applicant stating that he shall immediately inform

the DGF of any decision by the official authority(ies) of other States to

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withdraw the medicinal product from one of the markets for which it

was authorized;

e. declaration of the existence of marketing data, issued by the competent

body of the country for whose marketing authorization WHO

recognition or certification is being requested;

f. declaration to the effect that there has been no change to the

risk/benefit balance, issued by the competent body of the country that

granted the marketing authorization for which recognition is being

requested; and

g. a list of safety alerts relating to the medicinal product, issued by the

competent body of the country which granted the marketing

authorization for which recognition is being requested, if any.

CHAPTER III

Manufacturing

Article 25

Authorization

1. Without prejudice to the competence of other departments of State, the

manufacture of medicinal products shall be subject to prior authorization by

the DGF.

2. Preparations made up in pharmacies for a specific patient shall be exempt

from the provision contained in the preceding paragraph.

3. An appeal may be lodged in the case of refusal of the authorization provided

for in paragraph 1, in accordance with the legal provisions.

4. The authorization provided for in paragraph 1 shall be attested to by the DGF

through the issuing of a certificate, in accordance with the administrative

provisions in force at WHO.

Article 26

Application

The request for authorization referred to in the preceding Article shall be formulated

as an application containing the specification of the medicinal product, the

pharmaceutical form to be manufactured, the place of manufacture and the existence

of quality control capacity.

Article 27

Requirements

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1. The manufacturing authorization provided for in this Decree shall be subject to

the following requirements:

a. the applicant must have available adequate installations and

equipment, with the characteristics established under national

legislation;

b. there must be a full­time technical department;

c. staff must be competent, qualified and in sufficient numbers to achieve

the objectives of guaranteed pharmaceutical quality: and

d. minimum capital of CVE 5,000,000 (five million Cape Verdean

escudos) allocated to the activity, proof of which shall be provided

through presentation of registration in the commercial register

including the capital of the owner in sole proprietorship or partnership,

or information on the owner/partnership’s financial capacity provided

by a credit or non­bank institution.

2. The requirements provided for in the preceding paragraph must be confirmed by

the General Health Inspectorate and/or Inspection Service of the General

Directorate of Pharmacy and ARFA.

Article 28

Technical directorship

1. Individuals carrying out the functions of technical director must have a degree

in Pharmacy or in Pharmaceutical Sciences and at least five years’

professional experience, duly recognized in Cape Verde.

2. In the case of marketing authorization holders who personally fulfill the

requirements, they may assume the functions of technical director.

Article 29

Competences of the technical director

1. The technical director shall be responsible for all the pharmaceutical acts carried

out as a part of the manufacturing process, including, in particular:

a. compliance with the good manufacturing practices established by

WHO.

b. guaranteeing that each batch of medicinal products has been

manufactured and controlled in accordance with the good

manufacturing practices, following the methods and techniques

included in the respective marketing authorization dossiers;

c. implementing the quality policy with regard to the production and

control phases;

d. recording each product batch and preparing quality control reports, to

be made available to inspectors for at least a year after the expiry of

the batch;

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e. checking to ensure that the active substances and other raw materials

subject to processes of dividing up are analyzed in order to guarantee

their quality and purity;

f. certifying that the records guarantee all possible protection against

data falsification and ensuring that said records are kept;

g. ensuring the proper storage, packaging of medicinal products and raw

materials, whether they be active or not;

h. guaranteeing compliance with the specific legal provisions governing

narcotic drugs and psychotropic substances: and

i. introducing a procedure guaranteeing the recall of batches and a

sufficiently rapid response in a given situation.

2. The liability of the technical director shall not exclude, in any case, the liability of

the manufacturer.

Article 30

Time periods

1. Manufacturing authorization shall be granted within 120 days, starting from

the date of the request.

2. The time period referred to in the preceding paragraph shall be suspended

whenever additional information is requested, for the period fixed for

compliance with the request.

3. Decisions relating to requests for the variation of an authorization shall be

issued within 45 days of the submission of the request.

Article 31

Obligations of authorization holders

Manufacturing authorization holders shall be obliged to:

a. ensure that qualified staff are available to carry out manufacturing and quality

control activities;

b. manufacture only those medicinal products for which they have authorization;

c. introduce a pharmacovigilance procedure for compilation and the notification

of adverse reactions and events, in accordance with the technical guidelines

drawn up by the DGF;

d. comply with the principles of good medicinal product manufacturing practice

established by WHO and the respective manufacturing authorizations;

e. facilitate access for inspectors; and

f. comply with the other obligations provided for by law.

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Article 32

Suspension and revocation

The DGF shall revoke or suspend manufacturing authorization in cases where any of

the requirements deriving from the preceding Articles have not been observed.

Article 33

Variation

1. Requests for the variation of a manufacturing authorization, principally of some

of the elements referred to in Articles 26 and 27, shall be decided on within a

maximum of 30 days.

2. During the course of the time period referred to in the preceding paragraph, the

DGF may, in exceptional and duly substantiated cases, decide to extend

authorization for a period which may not exceed 90 days in total.

Article 34

Manufacture by third parties

Laboratories manufacturing pharmaceutical products may commission third parties to

carry out all or certain phases of the manufacturing or control process provided for by

this Decree, on the condition that they have been authorized to do so.

CHAPTER IV

Importation, exportation and marketing

SECTION I

Importation and exportation

Subsection I

General provisions

Article 35

Authorization

1. The importation and exportation of medicinal products for human use shall be

subject to prior authorization by the DGF and only medicinal products

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included on the National List of Medicinal Products, or listed on the register

in Cape Verde, may be imported or exported.

2. Requests for authorization shall be made using the form contained in Annex I

of the present Decree, the form being an integral part of the Decree on which

the activities for which a license is being requested shall be specified.

3. The form shall contain information regarding the documents to be provided

concerning each of the activities, along with the request for authorization,

without prejudice to the fact that, in cases of the simultaneous request for

authorization for more than one activity, only one copy shall be required for

the processing of the authorization request.

4. As a minimum, each batch of imported medicinal products shall be submitted

for qualitative and quantitative analysis with regard to the active substances,

as well as for any other tests required to demonstrate their quality, in

accordance with the respective marketing authorization.

5. Batches of medicinal products controlled in accordance with the requirements

contained in the preceding paragraph must be accompanied by the control

reports signed by the technician responsible.

6. The authorization provided for in paragraph 1 shall be certified by the DGF,

taking into account the administrative provisions in force at WHO.

Article 36

Requirements

1. Authorization for the activities of importation and exportation of medicinal

products shall be subject to the following requirements:

a. the applicant must possess adequate installations and equipment;

b. presentation of a draft manual of procedures for the area of activity;

c. the presence of a pharmaceutical technician who shall, effectively and

permanently, ensure and be responsible for compliance with the

requirements specific to the area of activity; and

d. minimum capital of CVE 5,000,000 (five million Cape Verdean escudos)

allocated to the activity, proof of which shall be provided through

presentation of registration in the commercial register including the capital

of the owner in sole proprietorship or partnership, or information on the

owner/partnership’s financial capacity provided by a credit or non­bank

institution.

2. The requirements provided for in the preceding paragraph must be confirmed

by the General Health Inspectorate and/or the Inspection Service of the

General Directorate of Pharmacy and ARFA.

Article 37

Application

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1. The authorization provided for in Article 35 shall be granted following an

application by the interested party, addressed to the Director General of

Pharmacy, which shall include;

a. details of the applicant (name);

b. address of head office or residence;

c. tax number;

d. details of the pharmaceutical technical director responsible for the

activity for which authorization is being requested; and

e. location of the premises where the required activity is to be carried

out.

2. Applications shall be accompanied by the following documents:

a. document attesting to the Technical Director’s qualifications;

b. a statement of responsibility from the Technical Director and, where

necessary, the statutes of the company which owns the premises where

the activity in question is to be carried out;

c. plan of the installations and equipment to be used for the activity, in

order to ensure proper storage and marketing of the medicinal

products; and

d. police records of the Technical Director and partners.

Article 38

Processing of dossiers

The DGF shall be responsible for the processing of dossiers involving authorization of

the activities of importation and exportation of medicinal products for human use.

Article 39

Inspection

1. Having checked that the application submitted is in order, the DGF shall plan

the inspection of the installations where the applicant intends to carry out the

activity. The inspection shall be carried out, at the applicant’s request, by the

Inspection Service of the DGF following payment of the previously prescribed

fee.

2. The aim of the inspection is to check that the installations and equipment

referred to in the documentation requested alongside the application comply

with the requirement mentioned in Article 37 of the present Decree.

3. In the case of installations which do not meet the conditions contained in the

preceding paragraph, the interested party shall have no less than 30 days to

correct the defects identified.

Article 40

Time periods

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1. The time period for the processing of the authorization request dossier by the

DGF shall be 60 days, from the date of completion of the inspection.

2. The time period shall be suspended whenever the DGF requests the applicant to

provide additional elements, or orders the correction of defects identified during

inspection.

Article 41

Grounds for rejection

1. Requests for the authorization of the activities of importation and exportation of

medicinal products shall be rejected should it be found that the applicant does not

meet the requirements contained in the present Decree, or in the other applicable

legislation.

2. Grounds for rejection shall consist, in particular, of:

a. the lack of a pharmaceutical technical director; and

b. the lack of installations which allow for medicinal products to be

properly stored and marketed, in accordance with the requirements

referred to in the “Good Marketing Practices”.

Article 42

Notification

1. The DGF must notify the applicant of the granting or rejection of the request

for authorization of the activities of importation and exportation of medicinal

products for human use.

2. In cases of rejection, the respective grounds for that decision shall be clearly

set out.

Article 43

Expiry of authorization

1. Authorization of the activities of importation and exportation of medicinal

products for human use shall expire should the interested party;

a. fail to begin the activity within six months of the date of the

authorization; and

b. suspend the activity for which the authorization was granted for a

period of more than 6 months.

2. The time period provided for in subparagraph (a) of the preceding paragraph may

be extended by the DGF once only, for an equal period of time, when duly

substantiated by a written document addressed to the Director of the DGF.

Subsection II

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Special Provisions

Article 44

Special importation

1. The Director General of Pharmacy may authorize the importation of medicinal

products not marketed in Cape Verde, waiving the provisions of Articles 36 and

37, under the following conditions:

a. when, through clinical justification, the products are considered to be

vital to the treatment or diagnosis of specific pathologies;

b. when the products are exclusively to be used for research and clinical

trials.

2. Where appropriate, the provisions contained in the preceding paragraph shall also

be applied to the importation of medicinal products based on the official WHO

certification system.

Article 45

Exportation of medicinal products

1. The exportation of medicinal products shall not be subject to the provisions

established in this Decree concerning packaging, labeling and presentation.

2. It shall be prohibited to export medicinal products which have been

withdrawn from the market because they are considered to be harmful to

public health;

3. For the purposes of exportation, the DGF must provide the summary of

characteristics of the respective medicinal product in accordance with the

terms under which it was approved.

SECTION II

Marketing

Subsection I

Wholesale marketing

Article 46

Authorization

1. The activity of wholesale marketing of medicinal products shall always

require the authorization of the DGF, except in the circumstances laid out in

the following paragraph.

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2. Holders of a manufacturing authorization granted under the present Decree

shall be exempt from the requirement to obtain the authorization provided for

in the preceding paragraph for the marketing of medicinal products that they

themselves have produced.

3. The authorization of the activity of wholesale marketing of medicinal products

for human use shall not provide exemption from authorization for importation

of medicinal products in cases where the products to be marketed are

manufactured outside of the national territory.

Article 47

Requirements

1. Wholesale marketing authorization shall be subject to the following requirements:

a. the applicant must have specialized installations for each specific step

in the area of activity in question, as well as appropriate equipment,

possessing the characteristics established in national legislation;

b. there must be a permanent technical department, which must comply

with the provisions of Article 28;

c. in accordance with this Decree, there must be a procedure in place

which establishes “Good Marketing Practices”

d. minimum capital of CVE 4,000,000 (four million Cape Verdean

escudos) allocated to the activity, proof of which shall be provided

through presentation of registration in the commercial register

including the capital of the owner in sole proprietorship or partnership,

or information on the owner/partnership’s financial capacity provided

by a credit or non­bank institution.

2. The requirements provided for in the preceding paragraph must be confirmed by

the General Health Inspectorate and/or the Inspection Service of the General

Directorate of Pharmacy and ARFA.

Article 48

Application

1. Wholesale marketing authorization shall be granted following a request by the

interested party, addressed to the General Directorate of Pharmacy, which must

include:

a. details of the applicant (name);

b. address of head office or residence;

c. tax number;

d. details of the pharmaceutical technical director responsible for the activity

for which authorization is being requested; and

e. location of the premises where the required activity is to be carried out.

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2. Applications shall be accompanied by the following documents:

a. registration of the Technical Director with the Ministry of Health;

b. a statement of responsibility from the Technical Director and, where

necessary, the statutes of the company owning the establishment where

the activity in question is to be carried out;

c. plan of the installations and equipment to be used for the activity, in

order to ensure proper storage and marketing of the medicinal

products; and

d. police records of the Technical Director and partners.

Article 49

Obligations of the authorization holder

Holders of authorizations to carry out the activity of wholesale marketing of medicinal

products for human use shall be obliged to:

a. comply with the internationally­recognized principles of good marketing

practice, approved at the national level;

b. maintain, at all times, a supply of medicinal products included on the National

List, for each therapeutic class, in sufficient quantities to meet promptly the

needs of the geographical territory determined at the time of the request for

authorization;

c. keep records of all the transactions involving medicinal products going back

at least five years;

d. only distribute those medicinal products with a marketing authorization and

ensure that, at the time of their dispatch to the recipient, they are within their

shelf life;

e. distribute the medicinal products exclusively to pharmacies, medicinal

product sales points and public or private health bodies holding an

authorization from the DGF, with direct sale to the public being prohibited;

f. refrain from distributing medicinal products which have been withdrawn from

the market by order of the competent authorities;

g. facilitate access for inspectors to premises, installations and equipment;

h. notify the DGF in writing, accompanied by all the relevant information, of any

significant modification of the installations or equipment initially authorized;

and

i. notify the DGF of any adverse reaction reported concerning the medicinal

products distributed.

Article 50

Records

1. The records referred to in subparagraph (c) of the preceding Article must

include, at the very least, the following information:

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a. date of transaction;

b. name, pharmaceutical form and presentation of the medicinal product;

c. quantity received or provided;

d. name and details of head office or residence of the supplier; and

e. details of the recipient.

2. The records required may be kept either in paper form or on computer,

provided that it can be guaranteed that the data recorded cannot be falsified

and that the legally required information will be safeguarded and kept.

3. The Technical Director shall be directly responsible for the establishment and

regular updating of the records.

Article 51

Suspension, revocation and prohibition

1. The DGF must suspend the exercise of the activity of wholesale marketing in

cases where the applicable legal standards and regulations are not observed.

2. The DGF may also suspend the exercise of the activity of wholesale marketing

when the applicant has substantially modified the installations or equipment

initially authorized without prior authorization.

Article 52

Regime

The activity of wholesale marketing of medicinal products shall be governed, with the

necessary changes, by the provisions contained in the preceding section, in particular

those contained in Articles 36­41.

Subsection II

Marketing regime

Article 53

Direct acquisition of medicinal products

1. Manufacturers, importers and wholesalers may only sell medicinal products

directly to the following bodies:

a. Pharmacies and medicinal product sales points;

b. Public or private health establishments and services and non­profit making

charities with medical and pharmaceutical services, provided that the

products are to be used by those services.

2. Manufacturers, importers and wholesalers may freely trade in medicinal

products between themselves.

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Article 54

Sale to the public

Medicinal products may only be sold to the public in pharmacies and medicinal

product sales points.

Article 55

Medical prescription

Medical prescriptions must identify the generic medicinal product by its INN or

generic name, followed by the strength and pharmaceutical form.

Article 56

Non­prescription medicinal products

The DGF shall be responsible for determining which medicinal products may be sold

without a medical prescription.

SECTION III

Technical Director

Article 57

Competences of the Technical Director

In the fields of importation, exportation and marketing, the Technical Director shall be

responsible for all pharmaceutical acts carried out, including in particular:

a. compliance with good medicinal product distribution practices provided

for by law, which shall necessarily be reflected in the written procedures;

b. checking that the medicinal products are included on the National List of

Medicinal Products (LNM) and/or have a national marketing

authorization;

c. guaranteeing that the medicinal products distributed comply with the legal

requirements concerning presentation, notably information in the

Portuguese language (packaging and package leaflet) and the presence of

stamps;

d. recording each batch received, distributed and exported, guaranteeing their

traceability and keeping those records available for inspectors for at least a

year after the expiry of the batch;

e. maintaining an archive of copies or originals of the release certificates of

each batch for at least a year after the expiry of the batch;

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f. ensuring the proper storage, packaging of medicinal products and raw

materials, whether they be active or not;

g. guaranteeing compliance with the specific legal provisions governing

narcotic drugs and psychotropic substances;

h. introducing a pharmacovigilance procedure for compilation and

notification of adverse reactions and events, in accordance with the

technical guidelines drawn up by the DGF;

i. notifying the DGF of any absence and ensuring the presence of a

replacement technical director.

CHAPTER V

Donations

Article 58

Appeal for donations

The following bodies may appeal for donations with the authorization of the DGF:

1. public health bodies;

2. religious organizations; and

3. non profit organizations.

Article 59

Requirements

1. All donations of medicinal products must be based on express needs and shall

be in accordance with Cape Verde’s morbidity.

2. The medicinal products may not be sent without the prior authorization of the

recipient.

3. All donated medicinal products or their chemical equivalents must be on the

National List of Medicinal Products.

4. The provisions contained in the preceding paragraphs shall be waived in the

following situations:

a. sudden outbreaks of diseases; and

b. the appearance of a new pathology.

Article 60

Guarantee of quality and in­use storage time

1. All donated medicinal products must originate from a reliable source and

comply with the international quality standards.

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2. Donations may not include medicinal products that have already been used

and returned, or free samples for health professionals.

3. At the moment of entry into Cape Verde of the donated medicinal products,

these products must have an in­use storage time of a minimum of a year,

unless they are destined for immediate delivery to health establishments, in

which case, the health professional responsible shall issue an opinion

concerning the shelf life of the medicinal products and the respective quantity.

Article 61

Presentation

1. The presentation, strength and formulation of the medicinal products donated

must be analogous to those of the medicinal products used in the country.

2. The written information (summary of product characteristics, package leaflet

and packaging) must be written in Portuguese, although the information may

be simultaneously presented in other languages.

3. All packaging must bear the following information as a minimum:

a. INN or generic name;

b. batch number;

c. pharmaceutical form;

d. strength;

e. name of manufacturer;

f. shelf life; and

g. quantity contained in the packaging.

CHAPTERVI

Advertising

Article 62

General principles

1. For the purposes of this Decree, advertising of medicinal products shall be

considered to be any form of information, canvassing or incentive aimed at

encouraging the prescription, dispensing, sale, acquisition or consumption of

medicinal products:

a. targeting persons qualified to prescribe or supply them;

b. through visits by medical sales representatives to the persons referred to in

the preceding subparagraph;

c. through the supply of samples;

d. through the gift, offer or promise of any benefit or bonus, whether in

money or in kind, except when their intrinsic value is minimal;

29

e. through sponsorship of promotional meetings attended by the persons

referred to in subparagraph (a);

f. through sponsorship of scientific congresses or meetings attended by the

persons referred to in subparagraph (a), and in particular through payment,

direct or indirect, of their travelling and accommodation expenses in

connection therewith; or

g. through references to the brand name of a medicinal product.

2. advertising of medicinal products in the public media shall be prohibited.

3. advertising of medicinal products for which marketing authorization has not

been granted shall be prohibited.

4. advertising may not deviate from the information contained in the summary of

product characteristics, as authorized.

5. advertising must encourage the sensible use of medicinal products, doing so in

an objective manner and without exaggerating the properties of the products.

6. advertising must be designed in such a manner as to ensure that the

commercial message is clearly expressed, it being stated that the subject of the

message is a medicinal product.

7. medicinal products may only be advertised in technical publications or

audiovisual information material exclusively aimed at doctors and other health

professionals.

Article 63

Prohibited advertising

1. Advertising of medicinal products may not contain any element which:

a. leads people to conclude that medical consultation or surgery is

unnecessary, in particular if a diagnosis is put forward or treatment by

correspondence is proposed;

b. suggests that the health of the patient may be affected should the

medicinal product not be used, with the exception of vaccination

campaigns;

c. refers to a recommendation made by scientists or health professionals;

d. leads to confusion of the medicinal product with a food product,

cosmetics or any other consumer product;

e. suggests that the safety or efficacy of the medicinal product is due to

the fact that it is a natural product; and

f. suggests that the medicinal product is guaranteed to have an effect and

that there are no side effects.

2. All forms of comparative advertising shall be prohibited.

3. The free distribution of medicinal products to the public for promotional purposes

shall be prohibited.

Article 64

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Advertising material aimed at health professions

1. Advertising material targeting professionals licensed to prescribe or dispense

medicinal products must include the following information as a minimum:

a. Summary of product characteristics;

b. Indication of the prescription, if any, or of the classification of the

medicinal product for dispensing purposes; and

c. The extent to which the price of the medicinal product is covered by

the State.

2. The information contained in the document referred to in the preceding paragraph

must be precise, up­to­date, verifiable and sufficiently complete to allow the

recipient to form an accurate idea of the therapeutic value of the medicinal

product.

3. Quotes and illustrative material taken from medical publications or scientific

works destined to be used in the material provided for in paragraph 1, must be

correctly reproduced and the respective source indicated.

4. Holders of marketing authorization or enterprises responsible for promoting the

product must maintain a scientific service responsible for the information relating

to the medicinal products they are putting on the market. Such services must hold

all the scientific information relating to the medicinal products, and to the

advertising activity carried out, in files which include details of the recipients,

method and date of first instance of dissemination of information.

Article 65

Incentives

1. Those responsible for promoting medicinal products shall be prohibited from

giving or promising, directly or indirectly, any benefit or bonus, whether in

money or in kind, except when their intrinsic value is minimal.

2. Those prescribing or supplying medicinal products shall be prohibited from

requesting or accepting any of the incentives provided for in the preceding

paragraph.

3. The provisions of the preceding paragraphs shall apply without prejudice to the

legally­established provisions concerning profit margins, prices and discounts.

Article 66

Free samples

1. Samples intended for the promotion of medicinal products may only be given to

persons licensed to prescribe, under the following conditions:

a. that they are the object of a request made by the recipient;

b. that they shall be identical to the smallest marketing presentation.

2. They shall bear the phrases “free sample”, “not for sale to the public”, or similar;

3. They shall be accompanied by a copy of the summary of product characteristics;

31

4. Samples of medicinal products containing narcotic drugs or psychotropic

substances may not be given out.

Article 67

Scientific and professional events and actions promoting medicinal products

1. Sponsorship by the holder of the marketing authorization, or the enterprise

responsible for the promotion of a medicinal product, of actions promoting

medicinal products, training and scientific events, such as congresses and

symposiums, must be referred to in the promotion material concerning the

medical products, as well as in documents concerning the participants and in the

works or reports published prior to such events or actions taking place.

2. The holder of the marketing authorization, or the enterprise responsible for the

promotion of a medicinal product, must keep the documentation referring to each

of the events or actions they have sponsored and that are referred to by this

Article with the service referred to in paragraph 1 of the preceding Article for a

period of five years and in a form that facilitates inspection at any moment by the

competent public services.

3. The abovementioned documentation must contain the following elements,

reproduced faithfully and completely:

a. the program of actions and events;

b. the details of the body carrying out, sponsoring and organizing the

actions and events;

c. copies of the scientific or professional communications released.

Article 68

Civil liability

1. The advertisers, advertising agencies and any other bodies carrying out

advertising activity, as well as the holders of the advertising media used or the

respective concession holders, shall have joint and civil liability, under

general terms, for prejudice caused to third parties as a result of the broadcast

of illegal advertising messages.

2. The advertisers shall be exempt from the liability provided for in the

preceding paragraph should they be able to prove that they did not have prior

knowledge of the message delivered.

CHAPTER VII

Inspection

Article 69

Competence

32

Verification of compliance with the rules contained in this Decree shall lie within the

competence of the General Health Inspectorate and/or the Inspection Service of the

General Directorate of Pharmacy and ARFA.

Article 70

Duty of information

Bodies authorized to carry out the activities within the scope of this Decree shall be

obliged to present the General Health Inspectorate and/or the Inspection Service of the

General Directorate of Pharmacy and ARFA with any information they may request.

Article 71

Inspection Activity

1. Inspections may be carried out, at any time, of enterprises, establishments or

premises where medicinal products are to be found, including narcotic drugs

or psychotropic substances, and the presentation of documents or records

relating to said products may be requested.

2. For the purposes of the preceding paragraph, the General Health Inspectorate

and/or Inspection Service of the General Directorate of Pharmacy and ARFA

may request the support of appropriate national or foreign bodies or experts.

3. Prior to inspection, officials shall identify themselves by means of ID cards or

credentials issued by the General Health Inspectorate and/or the General

Directorate of Pharmacy or ARFA, bearing reference to their power to carry

out inspections.

4. Should the body being inspected refuse to present the documents or records

and prevent inspection of the premises, the local police shall be requested to

cooperate in carrying out the task.

5. In the interests of coordination, the body or authority carrying out the

inspection shall inform the other bodies of this fact, as well as providing them

with the results and respective reports.

6. Following each inspection, a written report shall be prepared and filed with

the respective service, unless it forms a part of criminal proceedings.

Article 72

Quality control of medicinal products

1. The necessary quality control analyses shall be carried out at the national

laboratory for the quality control of medicinal products, without prejudice to

the fact that, under the protocols signed, they may be carried out abroad.

33

2. For the purposes set out in the preceding paragraph, the General Health

Inspectorate and/or Inspection Service of the General Directorate of

Pharmacy, or ARFA may collect samples of the medicinal products (in their

finished state or at any stage of production), as well as of the respective raw

materials and packaging materials.

3. The provisions of this Article shall cover medicinal substances, cosmetics,

products intended for the purposes of hygiene and/or prophylaxis and others

whose verification may be deemed appropriate by the Inspectorate.

Article 73

Seizure of unauthorized medicinal products

1. Medicinal products put on sale without the necessary authorization shall be seized

by the General Health Inspectorate and/or the Inspection Service of the General

Directorate of Pharmacy, or ARFA.

2. The medicinal products seized may not be used or be used in public health bodies,

upon proof of their quality.

Article 74

Inspection of medicinal products in transit

Inspection activity may be carried out whenever deemed necessary, including with regard

to medicinal products in transit.

Article 75

Duty of cooperation

Owners, directors, their representatives and workers at establishments dedicated to the

manufacture, storage and marketing of medicinal products, shall be obliged to:

a. facilitate the entry of all duly identified agents responsible for inspection into

their premises, establishments and offices, for the period deemed necessary;

b. present these agents with the documentation, accounting records, registers,

archives and other elements which may be requested and, also, to provide any

information and statements requested.

Article 76

Correction of defects

In cases in which the inspected bodies have not complied with the legal provisions,

without prejudice to any sanction arising from the case, the competent bodies may, in

34

accordance with Article 69, grant a reasonable time period for the correction of the

defects identified.

CHAPTER VIII

Offenses

Article 77

Infringements and fines

1. Without prejudice to criminal, disciplinary or civil liability or administrative

sanctions and measures which may be applied, infringements of the provisions

of this Decree shall constitute offenses punishable in accordance with the

terms of the following paragraphs.

2. The falsification of medicinal products or substances, as well as the sale,

acquisition or transport and/or storage for the purposes of marketing, of said

medicinal products or substances, shall constitute an offense, punishable with

a fine of CVE 500,000 to CVE 1,000,000.

3. The violation of the provisions of Articles 62 and 63 shall constitute an

offense, punishable with a fine of CVE 100,000 to CVE 200,000, which may

be applied along with the additional penalty of the suspension, for up to two

years, of advertising of the medicinal product.

4. The following shall constitute offenses punishable with a graduated fine of

CVE 500,000 to CVE 2,500,000 or up to CVE 5,000,000, depending on the

nature of the agent, i.e. natural or legal person:

a. the exercise of the activity of the manufacturing of medicinal products

for human use without prior authorization;

b. the importation into Cape Verde of medicinal products that are out of

date for marketing purposes;

c. the violation of the duty of public service in terms of the production of

quality medicinal products; and

d. the manufacture of medicinal products lacking the corresponding

marketing authorization and/or not included on the National List of

Medicinal Products;

5. The following shall constitute offenses punishable with a fine of CVE 200,000

to CVE 1,000,000 or up to CVE 2,000,000, depending on the nature of the

agent, i.e. natural or legal person:

a. the violation of the duty to ensure the presence of an effective and

permanent technical department at the authorized establishment;

b. the violation of the principles and standards of good manufacturing

practice;

c. the violation of the standards relating to the recording of production

and quality control operations; and

d. the marketing of medicinal products manufactured by bodies lacking

legal authorization;

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6. The following shall constitute offences punishable with a fine of CVE

200,000 to CVE 1,000,000 or up to CVE 2,000,000, depending on the nature

of the agent, i.e. natural or legal person:

a. the exercise of the activity of wholesale marketing of medicinal

products for human use without prior authorization;

b. the wholesale marketing of medicinal products without the necessary

marketing authorization, and/or of medicinal products not included on

the National List of Medicinal Products, or of medicinal products

whose withdrawal from the market has been ordered by the competent

authorities; and

c. wholesale marketing to persons or bodies lacking legal authorization.

7. The following shall constitute offenses punishable with a fine of CVE 100,000

to CVE 500,000 or up to CVE 1,000,000, depending on the nature of the

agent, i.e. natural or legal person:

a. the violation of the duty to ensure the presence of an effective and

permanent technical department at the authorized establishment;

b. the violation of the principles and standards of good marketing

practice;

c. the violation of the standards relating to the recording of medicinal

product transactions;

d. the marketing of medicinal products, the shelf life of which has

already expired on the date of their delivery to the recipient; and

e. the marketing of medicinal products without the respective stamps.

8. The technical director of the establishment shall be sanctioned as the co­

author of the offenses referred to in paragraphs 5 and 7.

Article 78

Application

1. The application of sanctions shall lie within the competence of the competent

bodies provided for in Article 69, except in the case provided for in the following

paragraph.

2. The application of the sanction of the closure of the installations of the distributor

and manufacturer, as well as the prevention of the conduct by the technical

department of its activities, shall be within the competence of the Ministry of

Health.

Article 79

Distribution of money collected through fines

The money collected as fines shall be distributed in the following manner:

a. 40 per cent for the Public Treasury;

b. 40 per cent for the services of the DGF; and

c. 20 per cent for the body applying the fine.

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Article 80

Appeals

In accordance with the law, despachos punitivos (documents summing up the

offense and sanctions to be applied) shall be open to appeal to the administrative

authority or to the administrative courts.

Article 81

Remaining cases

All cases of violation of this Decree not specifically provided for shall be

punished with fines from CVE 10,000 to CVE 80,000.

Article 82

Negligence and attempted violations

Negligence and attempted violations shall always be punishable.

CHAPTER IX

Final and transitional provisions

Article 83

Medicinal products included on the current National List of Medicinal

Products

Medicinal products included on the National List of Medicinal Products, be they

manufactured locally or imported, shall be subject to a request for marketing

authorization, within the time period set by the DGF.

Article 84

Costs

The costs of the acts relating to the procedures provided for in this Decree and of

the laboratory tests shall be met by the applicants, the rates being set by an Order of

the Ministers of Health and Finance.

Article 85

Notifications

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The notifications to the applicants referred to in this Decree must be sent by

registered post.

Article 86

Entry into force

This Decree shall enter into force 180 days after publication.

Article 87

Revocation

Decree­Law 3/93, of February 15, is hereby revoked

Seen and approved in the Council of Ministers:

José Maria Pereira Neves ­ Basílio Ramos ­ Cristina Duarte ­ João Pereira Silva

Promulgated on December 15, 2006

Let it be published

The President of the Republic

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