Regulatory Affairs and Pharmacovigilance

Megapharm’s goal is not simply to expand its portfolio of partner companies by providing a large range of medicines in Albania, but it is also to ensure that these drugs are used appropriately and safely.

Our Pharmacovigilance and Regulatory Service professionals have to evaluate the potential link between exposure to a new drug and any adverse effects that may have come about from its use. They have very good knowledge of Albanian and European pharmacovigilance legislation, and provide support to the applications for new licences.

The company’s Regulatory Service deals with the registration of the authorisation for new medicines, re-registration as per the NADME’s Rules of Procedures, and any variations.

*National Agency of Drugs and Medical Equipment

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