27th of August, 2015
New Legislation in the Pharmaceutical Sector
Keywords: Infrastructure & Projects, Retail & Consumer Goods, Commercial
New Legislation in the Pharmaceutical Sector
Decisions of the Minister of Health 425/2015 and 477/2015
The Minister of Health has issued two new decisions; (A) 492/2015 and (B) 477/2015. Below is a brief description of the two decisions, respectively.
(A) Decision 492/2015 regulating the registration of human drugs:
The decision repeals the decision 296/2009. The new decision adds amendments that impact financial requirements of applicants; tighten the drug testing process; and change the timeline of the registration process. The decision was poorly received by pharmacists, their syndicate and by local pharmaceutical companies. A lawsuit is pending before the State Council requesting the annulment of the decision.
The main changes introduced by the decision are the following:
- The new decision increases the overall number of drug derivatives/samples within the drug boxes. (The drug boxes are boxes kept by the authority, where each box includes all drugs composed of the same primary chemical formula. The new decision determines the number of the boxes to be 18 (the number of boxes was not determined under the old decision)). Pharmacists will face difficulties as they should expand their inventory to include the new approved variants. Pharmacists believe the decision is a favor done to large foreign pharmaceutical companies that try to register their brands.
- If a drug is approved for registration, the applicant shall pay the fees in order to receive the approval. I.e. the drug producer will need to pay the fees before she commercially benefits from that drug.
- A local drug producer may not transfer the ownership rights of a drug before the drug is domestically traded for three years at least.
(B) Decision 477/2015 regulating pharmaceutical companies that produce drugs for the treatment of virus C:
The decision repeals decision 192/2015 and introduces further obligations upon companies that produce drugs for virus C treatment.
Examples of the new obligations are the following:
The producing company shall only distribute the drug through authorized distributors and shall report (every 15 days) to the authorities information on the quantities of the drug produced.
The distributing companies, themselves, shall report data about the sold drugs to the authorities.
The decision reiterates the obligations stipulated in the previous decree in relation to reporting and filing obligations on pharmacists.
A copy of the decision 425 for 2015 (Arabic) can be accessed here.
A copy of the decision 477 for 2015 (Arabic) can be accessed here.
(A) Decision 492/2015 regulating the registration of human drugs:
The decision repeals the decision 296/2009. The new decision adds amendments that impact financial requirements of applicants; tighten the drug testing process; and change the timeline of the registration process. The decision was poorly received by pharmacists, their syndicate and by local pharmaceutical companies. A lawsuit is pending before the State Council requesting the annulment of the decision.
The main changes introduced by the decision are the following:
- The new decision increases the overall number of drug derivatives/samples within the drug boxes. (The drug boxes are boxes kept by the authority, where each box includes all drugs composed of the same primary chemical formula. The new decision determines the number of the boxes to be 18 (the number of boxes was not determined under the old decision)). Pharmacists will face difficulties as they should expand their inventory to include the new approved variants. Pharmacists believe the decision is a favor done to large foreign pharmaceutical companies that try to register their brands.
- If a drug is approved for registration, the applicant shall pay the fees in order to receive the approval. I.e. the drug producer will need to pay the fees before she commercially benefits from that drug.
- A local drug producer may not transfer the ownership rights of a drug before the drug is domestically traded for three years at least.
(B) Decision 477/2015 regulating pharmaceutical companies that produce drugs for the treatment of virus C:
The decision repeals decision 192/2015 and introduces further obligations upon companies that produce drugs for virus C treatment.
Examples of the new obligations are the following:
The producing company shall only distribute the drug through authorized distributors and shall report (every 15 days) to the authorities information on the quantities of the drug produced.
The distributing companies, themselves, shall report data about the sold drugs to the authorities.
The decision reiterates the obligations stipulated in the previous decree in relation to reporting and filing obligations on pharmacists.
A copy of the decision 425 for 2015 (Arabic) can be accessed here.
A copy of the decision 477 for 2015 (Arabic) can be accessed here.
New Legislation in the Pharmaceutical Sector
27 August, 2015
Keywords: Infrastructure & Projects, Retail & Consumer Goods, Commercial
New Legislation in the Pharmaceutical Sector
Decisions of the Minister of Health 425/2015 and 477/2015
The Minister of Health has issued two new decisions; (A) 492/2015 and (B) 477/2015. Below is a brief description of the two decisions, respectively.
(A) Decision 492/2015 regulating the registration of human drugs:
The decision repeals the decision 296/2009. The new decision adds amendments that impact financial requirements of applicants; tighten the drug testing process; and change the timeline of the registration process. The decision was poorly received by pharmacists, their syndicate and by local pharmaceutical companies. A lawsuit is pending before the State Council requesting the annulment of the decision.
The main changes introduced by the decision are the following:
- The new decision increases the overall number of drug derivatives/samples within the drug boxes. (The drug boxes are boxes kept by the authority, where each box includes all drugs composed of the same primary chemical formula. The new decision determines the number of the boxes to be 18 (the number of boxes was not determined under the old decision)). Pharmacists will face difficulties as they should expand their inventory to include the new approved variants. Pharmacists believe the decision is a favor done to large foreign pharmaceutical companies that try to register their brands.
- If a drug is approved for registration, the applicant shall pay the fees in order to receive the approval. I.e. the drug producer will need to pay the fees before she commercially benefits from that drug.
- A local drug producer may not transfer the ownership rights of a drug before the drug is domestically traded for three years at least.
(B) Decision 477/2015 regulating pharmaceutical companies that produce drugs for the treatment of virus C:
The decision repeals decision 192/2015 and introduces further obligations upon companies that produce drugs for virus C treatment.
Examples of the new obligations are the following:
The producing company shall only distribute the drug through authorized distributors and shall report (every 15 days) to the authorities information on the quantities of the drug produced.
The distributing companies, themselves, shall report data about the sold drugs to the authorities.
The decision reiterates the obligations stipulated in the previous decree in relation to reporting and filing obligations on pharmacists.
A copy of the decision 425 for 2015 (Arabic) can be accessed here.
A copy of the decision 477 for 2015 (Arabic) can be accessed here.
(A) Decision 492/2015 regulating the registration of human drugs:
The decision repeals the decision 296/2009. The new decision adds amendments that impact financial requirements of applicants; tighten the drug testing process; and change the timeline of the registration process. The decision was poorly received by pharmacists, their syndicate and by local pharmaceutical companies. A lawsuit is pending before the State Council requesting the annulment of the decision.
The main changes introduced by the decision are the following:
- The new decision increases the overall number of drug derivatives/samples within the drug boxes. (The drug boxes are boxes kept by the authority, where each box includes all drugs composed of the same primary chemical formula. The new decision determines the number of the boxes to be 18 (the number of boxes was not determined under the old decision)). Pharmacists will face difficulties as they should expand their inventory to include the new approved variants. Pharmacists believe the decision is a favor done to large foreign pharmaceutical companies that try to register their brands.
- If a drug is approved for registration, the applicant shall pay the fees in order to receive the approval. I.e. the drug producer will need to pay the fees before she commercially benefits from that drug.
- A local drug producer may not transfer the ownership rights of a drug before the drug is domestically traded for three years at least.
(B) Decision 477/2015 regulating pharmaceutical companies that produce drugs for the treatment of virus C:
The decision repeals decision 192/2015 and introduces further obligations upon companies that produce drugs for virus C treatment.
Examples of the new obligations are the following:
The producing company shall only distribute the drug through authorized distributors and shall report (every 15 days) to the authorities information on the quantities of the drug produced.
The distributing companies, themselves, shall report data about the sold drugs to the authorities.
The decision reiterates the obligations stipulated in the previous decree in relation to reporting and filing obligations on pharmacists.
A copy of the decision 425 for 2015 (Arabic) can be accessed here.
A copy of the decision 477 for 2015 (Arabic) can be accessed here.
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