Since 1 September 2021, pharmaceutical companies have been required by the French regulation to hold two months of security stocks of their products in France if they fall under the category of medicines of major therapeutic interest (MITM).
The stated aim is to more effectively deal with the risks of stock-outs and improve availability to patients. Several past shortages were widely covered by the media and resulted in the French Medicines Agency (ANSM) imposing financial penalties on pharmaceutical companies. Non-MITM drugs will also have to comply with a storage obligation, but for a shorter period, from one week to one month. The stocks may be established outside France.
The new obligations result from the decree of 30 March 2021, implementing the Social Security Financing Act of 24 December 2019 for 2020. They were meant to be applied since 1st September but the ANSM seems to agree that the pharmaceutical companies can wait until November 2021 to implement them.
However, there are two exceptions to the principle of two months of stock for MITMs. The first, which is favourable, is that pharmaceutical companies can obtain the agreement of the ANSM in order to reduce the stock requirement. An application form has already been prepared by ANSM, which must be signed by the responsible pharmacist. The second, on the contrary, is that the ANSM requires a stock higher than two months, up to a limit of 4 months, if there is a risk of stock-out or if there have already been several regular stock-outs over the past two years.
These are therefore new and onerous obligations for pharmaceutical companies, which some organizations still consider insufficient, despite the fact that France is already taking an isolated position in Europe.
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