With the announcement of Social Security Institute dated 30 June 2022, “Procedures and Principles on Applications on Reimbursement of Pharmaceuticals” is published and entered into force.
The below issues are provided by the updated procedures and principals in general:
· The terminology adopted in the Ministry of Health legislation (original – reference, generic – equivalent) is used in the definitions.
· The definition of biosimilar medicinal product is added.
· Products that are allowed to be sold by the Ministry of Agriculture and Forestry is excluded from the scope.
· Some issues such as company, barcode, and product name changes are removed from the article regarding the content of the application file, and applications on these issues are regulated in Annex-1B named "Application Form for Changes in Pharmaceutical Information".
· Commitments regarding the price of products, supply of medicines, compliance with legislation and company’s responsibility are added to Annex-3A.
You can reach the updated procedure and principals vis the link below:
https://lnkd.in/dwNqpGJV