The exportation of drugs and pharmaceutical products is mainly regulated by the Ministerial Decree No. 379 of 1986. Under this decree, the exportation of drugs and pharmaceutical products is not allowed unless they are registered with the MoH. Pharmaceutical product listed under a pharmacopeia may not be exported unless their cards are certified by the MoH.
As a general requirement, any company undertaking exportation activities must be registered with the relevant exports register in GOEIC.
To ensure the availability of pharmaceutical products in Egypt, companies manufacturing such products are not allowed to export any quantities thereof in case they are not available at the local market. The competent department at CAPA shall be responsible for determining the existence of any shortage concerning such product.
Before exporting any pharmaceutical product, except for personal exportation, registration samples and bidding, the competent inspector in CAPA shall analyze a sample of each batch thereof at NODCAR which shall issue a decision regarding its conformity.
NODCAR is obliged to give priority to exported products in conducting its examination. However, in case it does not issue its decision within two weeks from the date of receiving samples, CAPA is entitled to permit the manufacturing company to export its products based on the analysis certificate issued by the company's laboratories and upon its own responsibility.
Pharmaceutical companies licensed by CAPA as well as companies which manufacture products according to foreign manufacturing agreements, permitting the exportation, are allowed to export their products outside Egypt.
Medical chemicals can be exported if they have been recently analyzed by NODCAR and in compliance with the medical pharmacopeias and certified technical specifications.
CAPA allows the exportation of products with expired registration provided that their relevant re-registration files have been submitted to CAPA.
Exporting drugs from Egypt either locally manufactured or imported is prohibited without following the regulations of exportation issued by the MoH. Whoever violates the foregoing shall be subject to imprisonment and/or a fine of a minimum amount of EGP 500 and maximum amount of EGP 1000. The foregoing penalty shall be doubled in case of recurrence. In all cases, the products which are the subject matter of the violation shall be confiscated.
Originally published March 07, 2017
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