Law No. 1 of 1986 on the Registration of Pharmaceutical Companies and their Products

Law Summary Record Type: LawNumber: 1Date: 03/02/1986 Corresponding to 24/05/1406 HijriNumber of Articles: 19Status: In force

Official Gazette :Issue: 2Offcial Journal Issue Publication Date: 01/01/1986 Corresponding to 20/04/1406 HijriPage from: 2073

طباعة

Articles (1-19)

We Khalifa bin Hamad Al-Thani, Emir of the State of Qatar;
Having perused the Amended Provisional Constitution, in particular Articles 23, 34, and 51 thereof,
Law No. 11 of 1962 establishing a Commercial Register, and its amendments,
Law No. 5 of 1970, specifying the competent authorities of ministers and the competencies of the ministries and other government authorities, as amended,
Law No. 14 of 1971 promulgating the Penal Code of Qatar;
Law No. 15 of 1971 promulgating the Criminal Procedure Law;
Law No. 3 of 1975 on commercial shops; either industrial or wholesale outlets and those trading to the public;
Law No. 3 of 1983 regulating the professions in pharmacy, pharmaceutical Intermediaries and Agents of Drug Factories and Companies
Law No. 5 of 1983 on the suppression of fraud in commercial transactions,
The proposal of the Minister of Public Health;
The draft law submitted by the Council of Ministers;
Having consulted the Shura Council,
Hereby promulgate the following law:

Articles

Article 1

In applying the provisions of this law, the following terms and expressions shall have the meanings assigned to them unless the context requires otherwise:

“Pharmaceutical companies” means companies and factories operating in the State of Qatar, either locally or foreign-owned, producing, or involved in the brokering of, pharmaceutical goods and medicines;

“Drugs” means medicines, drugs and pharmaceuticals preparations;

“Pharmaceutical establishments” means public and private pharmacies and drug stores and warehouses or stores of the brokers and agents involved in the pharmaceutical industry, factories and pharmaceutical companies;

“Registration Committee” means the Committee for the registration of pharmaceutical companies and their products;

Article 2

The pharmaceutical companies may not operate in the State of Qatar, nor shall any of their goods or medicines be available for sale, until the satisfactory completion of the registration procedures set forth in this law and unless there is satisfactory compliance with this law, bylaws and resolutions required by the competent official authorities or provided for by any other laws.

Article 3 (Amended By Law 5/2011)

A permanent committee for the registration of pharmaceutical companies and their products shall be established at the Supreme Council for Health. This committee shall be called the Permanent Licensing Committee (PLC) for the registration of pharmaceutical companies and their Products.

Article 4

The Minister of Public Health shall issue a resolution to form the Permanent Licensing Committee and outline its remit and working practices. The resolution shall specify the conditions, data and documents required for the registration of pharmaceutical companies and their products.

Article 5

The Permanent Licensing Committee shall prepare the following registers:

1- Applications register for the purpose of joining the register of pharmaceutical companies and their products.

2- Pharmaceutical companies register; and shall include the names of pharmaceutical companies approved by the Registration Committee.

3- The Medications Register shall list those medicines approved by the Registration Committee.

The mentioned registers shall be listed with corresponding serial numbers.

Article 6

Registration applications shall be submitted to the Permanent Licensing Committee after fulfillment of the conditions set forth by this law, and submission of the required data and documents.

Successful applications shall be added to the relevant register and the applicant shall be granted an acknowledgment stating the number and date of their registration.

The Committee shall issue its decision on the application within two months of the date of its receipt.

When the Committee issues a rejection of an application the grounds for this rejection must be justified and the applicant must be notified of this decision within a maximum of two weeks after this rejection has been issued.

An applicant who has been rejected may appeal to the Minister of Public Health within two months from the date of their notification of this rejection.

The petition must include a rebuttal of the reasons given for the rejection of the application, and must be accompanied by all the necessary supporting documents.

The Minister of Public Health shall issue his resolution to either reject the appeal or resolve that this application be reconsidered by the Committee.

Nor is the Committee's decision after an application is reconsidered by the Committee to be regarded as final unless it has subsequent approval by the Minister.

Article 7

The Permanent Licensing Committee shall publish in the Official Gazette periodically the names of those pharmaceutical companies and medicines that have been registered and all the amendments or additions thereto.

Article 8

Pharmaceutical companies and pharmaceutical establishments shall notify the PLC, with details of any changes in the medicines or pharmaceutical goods they hold or supply, during the month following the acquisition or change of these medicines.

The notification shall consist of a letter to the Registration Committee, according to a sample or template provided by the Registration Committee, and shall elaborate the drug names, types, quantities, their source, their date of acquisition and all other information mentioned in the sample form. This letter shall also include relevant supporting documentation.

Article 9 (Amended By Law 2/1998)

The registration of drugs does not entail the exemption of the pharmaceutical companies that manufacture or trade in them from liability in accordance with the general rules prescribed in this regard.

The owner of the company along with associated agents, mediators and importers in Qatar state may be held responsible for any violations of the provisions of this law or the regulations and resolutions it elaborates.

Article 10 Cancelled (Repealed By Law 5/2011) (Amended By Law 2/1998)

Article 11

Subject to the provisions of Article 13 of this law, the committee may, after hearing testimony from relevant stakeholders, decide to repeal or strike-out the registration of a company in the following cases:

1- When there is proof that a company's registration has been achieved fraudulently, by using fraudulent methods or other illegal means.

2- When the company does not provide in Qatar its registered pharmaceutical products for more than three months unless there are reasonable grounds which are acceptable to the Commission for this delay.

3- When there is a violation of the provisions of Article 8 of the law.

The company shall announce the resolution of the Commission within two weeks from the date of its issuance and the company shall have the right to appeal against the resolution of the Commission to the Minister of Public Health within two months of the promulgation of the resolution.

The Minister may issue a decision to either reject the appeal or advise its reconsideration by the Committee. Nor is the Commission's decision after an application is reconsidered by the Committee to be regarded as final unless it has subsequent approval by the Minister.

Article 12 (Amended By Law 5/2011)

Subject to the provisions of Article 13 of this law, the PLC may, after hearing testimony from relevant stakeholders, decide to repeal or strike-out the registration of a medicine in the following cases:

A- When there is proof that a medicine's registration has been achieved fraudulently, by using fraudulent methods or other illegal means;

B - When the Company does not, within one year, import the drugs or pharmaceutical goods which have been registered, unless there are reasonable grounds which are acceptable to the PLC for this delay;

C - The unavailability of registered pharmaceutical products with the agent for more than three months unless there are reasonable grounds which are acceptable to the PLC for this delay.

D - The expiration of a drug's use-by date or proof of toxicity or unacceptable side effects according to a report of the technical authorities of the Supreme Council of Health or according to specialised and recognised international organisations.

E - Proof that the state of origin of the drug or pharmaceutical good does not allow its use.

F- When any persons amend or alter the composition, prescription, packages, and containers of a drug before obtaining the required approval of the Registration Committee.

Article 13 (Amended By Law 2/1998)

Without prejudice to any more severe penalty provided by another law, the following shall be punished by imprisonment for a period not exceeding three years or a fine not exceeding ten thousand (10,000) Riyals, or either of them:

Owners of pharmaceutical companies or their mangers, agents, intermediaries and importers which traded or operated in Qatar without first being properly listed in the relevant register;
Any person who publicises, promotes, sells or dispenses a drug which is not registered in accordance with the provisions of this law;
Any person who establishes or registers a company or pharmaceutical drugs or medicines by fraud, or by using fraudulent methods or other illegal means;
Any persons who amend or alter the composition, prescription, packages, and containers of a drug before obtaining the required approval of the Registration Committee.

Article 14

Whoever infringes or violates the provisions of Article 8 of this law, shall be punished by imprisonment for a period not exceeding one year and a fine not exceeding three thousand (3000) Riyals, or either penalty.

Article 15

Members of the Permanent Licensing Committee and those who are invested with such authority by a resolution by the Minister of Public Health shall have investigative powers in order to prove and substantiate that violations of the provisions of this law have occurred. These individuals shall also oversee the proper implementation and enforcement of these by-laws and regulations.

Such judicial officers shall at any time, have the authority to access public places stipulated in this Law, access and inspect registers and documents, examine existing medicines and pharmaceutical products, machines, tools and take such samples as is necessary for forensic and laboratory analysis.

Article 16

Pharmaceutical companies and pharmaceutical establishments operating in Qatar shall amend their conditions and practices in order to remain compliant with the stipulations of this law within six months from the date it comes into effect.

Article 17

The Minister of Public Health shall issue the regulations, by-laws and resolutions necessary for the implementation of this law according to its provisions.

Article 18

Any provision which violates the provisions of this law shall be repealed.

Article 19

All concerned authorities, each within its competence, shall implement this legislation, which shall come into force six days after the date of its publication in the Official Gazette.