WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Close this folderAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
View the documentIntroduction
View the documentDrafting national legislation: points for consideration
View the documentDefining the scope of the marketing authorization procedure for medicinal products
Open this folder and view contentsExample of a legislative scheme for regulating medicinal products
View the documentReferences
View the documentSelected bibliography
View the documentAppendix 1. Provisional legislative scheme for registration of pharmacy personnel
View the documentAppendix 2. Guidelines, documents and other regulatory instruments established by WHO to support drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

Appendix 1. Provisional legislative scheme for registration of pharmacy personnel

In order to assist countries to update existing laws or to draft new ones, this document offers a provisional legislative scheme on registration of pharmacy personnel. The text and provisions should be adapted to suit national conditions, requirements and situations.

1. No person shall practise as a pharmacist unless his or her name has been registered as a pharmacist by the licensing authority by virtue of this Law.

2. An applicant for registration as a pharmacist must:

(a) hold a pharmaceutical qualification granted by a university or institution of equivalent standing;

 

(b) have practised the pharmaceutical profession for a period of not less than two years;

(c) be in good health and have no police record;

(d) fluently speak and read the national language and possibly others;

(e) pass such an examination as the minister may consider necessary.

 

3. Except as is provided by this Law, no person other than a person registered as a pharmacist shall:

(a) conduct and administer a registered pharmacy;

 

(b) in the course of any trade or business prepare, mix, compound or dispense any medicinal product or poison except under the supervision of a pharmacist; or

(c) assume, take, exhibit or in any way make use of any title, emblem or description reasonably calculated to suggest that he or she is registered as a pharmacist.

 

For the purpose of subsection (c) of this section the use of the word "pharmacist" or "chemist" or "druggist" or any similar word or combination of words shall be deemed to suggest that the owner of the business on those premises is, or purports to be, a registered pharmacist.

4. No person shall practise as a pharmaceutical technician or as an assistant in pharmacy unless he or she has obtained registration as a pharmaceutical technician or assistant in pharmacy by the licensing authority by virtue of this Law.

5. An applicant for registration as a pharmaceutical technician or assistant in pharmacy must:

(a) hold a recognized certificate as a pharmaceutical technician or assistant in pharmacy;

 

(b) have practised within the pharmaceutical profession for a period of not less than two years in a pharmacy under the supervision of a pharmacist;

(c) be in good health and have no police record;

(d) fluently speak and read the national language and possibly others;

(e) pass such an examination as the minister may consider necessary.

 

6. The applications for registration under sections 2 and 5 of this Law must be made in accordance with the regulation issued by the minister.

7. The licensing authority shall maintain a register of pharmacists and technicians or assistants in pharmacy.

8. Pharmacists and technicians or assistants in pharmacy must perform their duties in accordance with the ethics of the pharmaceutical profession and in particular must:

(a) at all times act in the interest of the patient;

 

(b) uphold the honour and dignity of the pharmaceutical profession and not bring the profession into disrepute;

(c) at all times have regard to the laws and regulations applying to medicinal products and pharmaceutical practice, and maintain a high standard of professional conduct;

(d) respect the confidentiality of information acquired in the course of their professional practice;

(e) offer services to the public in premises which reflect the professional nature of pharmacy.

 

9. The minister shall by regulation establish a pharmaceutical practice committee ideally comprising:

(a) a pharmacist chairman appointed by the minister;
(b) three registered pharmacists;
(c) two registered technicians or assistants in pharmacy;
(d) one lay member.

 

10. The pharmaceutical practice committee shall:

(a) advise the minister on any matter relating to the pharmaceutical profession and the practice of pharmacy;

 

(b) ensure the maintenance of high standards of practice and conduct among pharmacists and technicians or assistants in pharmacy and promulgate codes of conduct;

(c) set standards of education and training, where appropriate, for pharmacists and/or technicians.

 

The pharmaceutical practice committee may regulate its own procedure.

11.1 The minister shall by regulation establish a disciplinary committee to inquire into the conduct of a registered pharmacist or registered technician or assistant in pharmacy whom it is alleged has been convicted of a criminal offence or is in breach of any of the provisions of section 8 of this Law.

11.2. The disciplinary committee shall ideally comprise:

(a) a chairman with a legal background, appointed by the minister;
(b) two registered pharmacists;
(c) one registered technician or assistant in pharmacy.

 

No member of the pharmaceutical practice committee shall be a member of the disciplinary committee.

11.3 The disciplinary committee shall, after inquiry, have power:

(a) to issue a reprimand/warning to a registered pharmacist or registered technician or assistant in pharmacy;

 

(b) to adjourn an inquiry with conditions;

(c) to recommend to the minister that the name of a registered pharmacist, a registered technician or assistant in pharmacy be suspended or removed from the respective register;

(d) to regulate its own procedure.

 

12. The minister, by regulation, may fix fees for the initial registration of pharmacists, technicians or assistants in pharmacy, and pharmacies. Annual fees may also be payable to retain the names of pharmacists, technicians or assistants in pharmacy, and pharmacies on the respective registers.

13. Any person who contravenes section 1, 3 or 4 of this Law shall be guilty of an offence and liable to a fine not exceeding [amount to be specified].

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