Obtaining a prior consent from CAPA before selling a pharmaceuticals factory or changing its ownership of management was a requirement until 2016 (as per Ministerial Decrees no. 300 of 2000 and 497 of 2014).
This approach has been changed by the issuance of the Ministerial Decree 37 of 2016 which allows the selling of a pharmaceutical factory or changing its ownership or management by submitting a mere notification to CAPA alongside certain undertakings related to the availability of the products.
Decree 37 of 2016 no longer requires a prior consent of CAPA as it clearly stipulates that any contradicting provisions are overruled. Notifications and undertakings need to be submitted according to with Decree 37 of 2016 are as following:
- Detailed report by the seller on the status of the factory and its compliance with the technical requirements, and the registered products and its availability in the market, its inventory, and the manufacturing and importation plans.
- An undertaking from the buyer to ensure the availability of the pharmaceutical products available in the market and not to undertake any changes that would result in affecting such availability during the first 6 months after transferring the ownership without obtaining a prior written approval from CAPA.
- According to Decree 37 of 2016, the buyer is obliged to keep the rights of the employee of the transferred factory. Violating this decree can result in suspending the license of the factory.
March 07, 2017
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
