Finished product approval

Medicinal products must obtain marketing authorisation prior to their placement on the market. The European Commission grants marketing authorisation following a positive opinion from the European Medicines Agency (EMA) or the national agency for medicinal products. Marketing authorisation is granted when the product registration dossier unambiguously proves that the medicinal product is high-quality, safe, and efficient.

The results of preclinical and clinical studies are an essential part of the registration dossier. Studies are conducted in line with the latest professional and regulatory guidelines. Successfully completed studies provide the final approval of product safety and efficacy. They are the basis for successfully completing marketing authorisation procedures and placing a medicinal product on the market.

The results of preclinical and clinical studies are an essential part of the registration dossier. Studies are conducted in line with the latest professional and regulatory guidelines. Successfully completed studies provide the final approval of product safety and efficacy. They are the basis for successfully completing marketing authorisation procedures and placing a medicinal product on the market.

We ensure that our products are of high quality and in compliance with the latest scientific findings, guidelines, and requirements throughout their lifecycles. Any changes we might implement are always assessed and approved by the relevant regulatory authorities.