Resolution No. 20 of 2000 by the Minister of Public Health on the Formation of the Standing Committee of the Registration of Pharmaceutical Companies and of their Products, Functions and Modus Operandi

Law Summary Record Type: Ministerial DecreeNumber: 20Date: 31/12/2000 Corresponding to 05/10/1421 HijriNumber of Articles: 12Status: In force

Official Gazette :Issue: 1Offcial Journal Issue Publication Date: 10/02/2001 Corresponding to 17/11/1421 HijriPage from: 433

طباعة

Articles (1-12)

The Minister of Public Health,
Having reviewed the Amended Provisional Constitution, in particular Articles 33 and 34 thereof;
Law No. 3 1983 on the Regulation of the Pharmaceutical Profession and the Intermediaries and Agents of Pharmaceutical Factories and Companies;
Law No. 1 of 1986 on the Registration of Pharmaceutical Companies and their Products, as amended by Law No. 2 1998;
Decree Law No. 10 of 1993 organizing the Ministry of Public Health and specifying its functions;
Emiri Resolution No. 29 1996 on the resolutions of the Council of Ministers submitted to the Emir for approval and issuance;
Ministerial Resolution No. 4 1986 on the formation of the Standing Committee of the Registration of Pharmaceutical Companies and of their Products, Functions and Modus Operandi;
And the draft resolution No. 31/ 2000 adopted by the Council of Ministers at its regular meeting held on 18/10/2000;
Hereby resolves as follows:

Articles

Article 1

1. The Standing Committee for the registration of pharmaceutical companies and their products (hereinafter “the Committee”), as stipulated by Law No. 1 of 1986 referred to above, shall be formed as follows:

Director of the Department of Pharmacy and Drug Control at the Ministry of Public Health (Chairman)
Head of the Department of Drug Registration and Pricing at the Ministry of Public Health - (Vice-Chairman)
Four members of the Ministry of Public Health and Hamad Medical Corporation selected by the Minister.

The Vice-Chairman shall replace the Chairman in his absence or where his office is vacant.

Article 2

The Committee shall assume the registration of the pharmaceutical companies and their products and exercise all the powers set forth in Law No. 1 of 1986 referred to above, in particular the following:

Receiving applications for the registration of pharmaceutical companies and their products, registering these applications in the book allocated therefor, and furnishing the applicant with a receipt reflecting the number and date of registration.
Examining the registration of applications and refusing such registration where justified.
Conducting a search of pharmaceutical companies that change or add to their drug products, and approving or rejecting their registration.
Recording pharmaceutical companies approved by the Committee in the pharmaceutical companies record under a specific serial number, recording this number on the external and internal medicine cards, and furnishing the applicant with a certificate thereof.
Recording the names of medicines approved by the Committee in the record under a specific serial number, recording this number on the external and internal medicine cards, and furnishing the applicant with a certificate thereof.
Receiving notifications from pharmaceutical companies and establishments of their types and quantities of medications, any changes in possession thereof, and any data requested by the Committee.
Preparing forms and records necessary for registration.
Publishing the names of pharmaceutical companies and products that have been recorded regularly in the Official Gazette, as well as all amendments or additions thereto approved by the Committee.
Considering possible violations by pharmaceutical companies and establishments of the provisions of Law No. 1of 1986, referred to above; taking the necessary measures to cancel their registration where such violations are proved; and cancelling the registration of any medication that violates the prescribed specifications.
Issuing periodic bulletins on pharmaceutical companies, establishments and products.

Article 3

The following documents shall accompany an application for the registration of pharmaceutical companies:

A certificate from the company that it is the sole agent in the State of Qatar. Such certificate shall be certified by the Embassy of the State of Qatar or its substitute in the country of origin.
A list of drugs produced by the company, together with the prices at which such drugs are sold to the public in the country of origin.
A list of the names of the company's branches and a description of their activities in producing or packaging drugs, as well as a statement of the company's liability regarding such activities.
A certificate from the competent health authorities in the country of origin authorizing the use and distribution there of the company's drugs.
A certificate from the competent health authorities in the country of origin that the company applies best practice principles in the manufacture of drugs.
A report on the company's research and innovations during the past ten years prior to the application for registration.

Article 4

The following documents shall be lodged with the application to register a pharmaceutical company:

A certificate from the health authorities in the country of origin authorizing the use there of the company's products. Such certificate shall be certified by the Embassy of the State of Qatar or its substitute in the country of origin.
A certificate approved by the health authorities in the country of origin indicating the name of the drug and the composition and quantity of its active substances.
A detailed statement about the properties of chemical and natural drugs and a quantitative and qualitative analysis.
At least six samples of the drug, each carrying a packaging label reflecting the following information:

1. Name of the drug.
2. Batch number.
3. Date of manufacture.
4. Expiration date.
5. Storage method.
6. Name of the pharmacopeia of the drug.
A certificate on the analysis of the drug in its final form.
Standard samples of the active materials used in the composition of the drug.
A statement of the manufacturing stages of drugs of the same batch number.
A study of the stability of the drug and the duration of its validity under different storage conditions, together with the prescribed storage temperature and humidity level.
A statement on the impact of pharmacological, clinical and toxicity studies of the drug published in international scientific magazines.
A statement of any change that may arise in the name or composition of the drug.

Article 5

Companies registered in a country which is a member of the Gulf Cooperation Council for the Arab States of the Gulf shall not be required to comply with the certification requirements set forth in Articles 3 (1) and 4 (1) of this resolution. The signature of a registry official at the Ministry of Health in these countries shall be sufficient.

Article 6

1. The Committee shall hold meetings once a month and whenever necessary, and no meeting shall be valid unless attended by a majority of the members.

Decisions shall be issued by majority vote of the members present. Where there is a deadlock, the Chairman shall have a casting vote.

Article 7

The minutes of the Committee's meetings shall be signed by the Chairman and members present and its decisions shall be recorded in a special register and signed by the Chairman.

Article 8

In the performance of its work, the Committee shall review data or documents it deems necessary and may also seek the assistance of staff or experts and obtain their opinion on any issue, or assign them to perform work under its terms of reference. Such staff or experts shall, however, have no right to vote.

Article 9

Agents of registered pharmaceutical companies and those responsible for their management shall facilitate the task of the members of the Committee and provide all data and information they require.

Article 10

During the first half of the month of December of each year, the Committee shall submit to the Assistant Undersecretary for Technical Affairs a report containing data and statistics on pharmaceutical companies and products, as well as the companies' names, nationalities, headquarters and branches, typesand quantities of drugs and methods of distribution, and any changes or additions thereto during the year.

Article 11

Ministerial Resolution No. 4 of 1986, referred to above, and any provisions that violate this resolution shall be repealed.

Article 12

All competent authorities, each within its own jurisdiction, shall implement this resolution which shall take effect from the date of its publication in the Official Gazette.