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Drug Registration in Romania
According to Romanians laws, medicinal products for human use can be marketed only after the granting of Marketing Authorization by the National Medicines Agency. The Marketing Authorization is granted for medicinal products for human use, which fulfill the quality, safety and efficacy conditions mentioned in the present regulations.
The National Medicines Agency authorizes for marketing the following medicinal products for human use:
- products which contain chemical substances;
- radiopharmaceutical products;
- biological products;
- phytotherapeutic products;
- homeopathic products;
- products obtained through biotechnology.
Find out more about drug registration in Romania by reading this report!
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