A draft document containing the expected new fees concerning the pharmaceutical industry was published on the website of the Bulgarian Ministry of Health. The marketing authorisation holders (MAHs) are now expected to have the opportunity to pay reduced fees for grouped variations which is currently not possible. Some other fees are reduced as well, e.g. line extensions and MAH transfer.
On the other side the fees for most of the marketing authorisation procedures (MRP, DCP and purely national procedure) are increased between 25% – 36%. The fee for purely national marketing authorisation procedure for generics remains less affected – increased with 7%. However, the annual fee for marketing authorisations is drastically increased with 300% and the fee for CPP (certificate of pharmaceutical product, WHO format) is increased with 200%.
Some new fees are introduced, e.g. for review and assessment of direct healthcare professional communication (DHPC) and risk minimisation educational materials and changes thereof. Currently there are no such fees.
The overall effect of the proposed amendments is expected to be increased financial pressure for the MAHs. The draft document might be subject to further changes but the trends are clear.
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