30 March 2023
09 Ramadhaan 1444
عربي
Article 12 - (Amended By Law 5 /2011) Starting Date : 31/03/2011 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 12 - (Amended By Law 5 /2011) Starting Date : 31/03/2011
Last Article Text Starting Date : 01/01/1986 Expiry Date: 31/03/2011
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 Ministry of Public 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.