The Finnish Medicines Agency Fimea have updated their Q&A, including questions in English

The Finnish Medicines Agency Fimea continually update their Q&A regarding safety features. The updated questions include questions on alert handling.

The full document is available here: 

https://www.fimea.fi/documents/160140/741488/Turvaominaisuudet+kysymyks…

Below we have listed the new questions that are in English.

- Question: It is our understanding that all parties (3PLs, wholesalers etc.) who have a contract with an MAH to distribute products on the MAHs behalf, must be listed as a designated wholesaler in the Master Data. We’ve also understood the fiscal ownership is irrelevant and deciding issue in whether a party should be listed or not, is whether they act on the MAHs behalf. Is this interpretation correct?

- Question: We understand that we should send a list of OTC packages with ATD to Fimea. Does this apply to marketed packages only? In some cases we have only an immediate package with a feature that relieves tampering. This feature is already described in the marketing authorisation (3.2.P.7 Container Closure System). Does Fimea still want a separate ATD notification regarding these OTC packages?

- Question: Could you please confirm: If there are no changes to the layout of the mock-up when adding the safety features (and conditions listed on Fimea webpage are fulfilled), there is no need to submit the mock-ups for information to Fimea?

- Question: For new newly applied products (MA applications) does the ATD need to be visible on the mock-ups that are submitted to Fimea?

- Question: Is it possible to already now print “PC:”, “SN:” on the packages, but without printing/including the actual numbers/2D code on the produced packages until after the 9 February 2019?

- Question: Once it is time to include the Unique identifier (PC number, SN number and 2D code) on the package, we would like, at the same time, to remove the existing barcode. Can this be done without submitting updated mock-ups (with removed Barcode) for information/approval to Fimea?

- Question: Braille text: If we need to move the Braille text slightly on the carton (but keep it on the same panel), in order not to be covered by the ATD (sticker label), is it then a requirement to submit the mock-ups for information/approval to Fimea (considering that there are no other layout changes to the mock-up)?

- Question: Is it allowed to replace the national abbreviations for expiry date “käyt.viim.” and batch number “erä nro” with abbreviations “EXP” and “LOT” without sending a 90-days notification if no other changes are made on the mock-ups?

- Question: Is it allowed to have preprinted prefixes (PC, SN, EXP, LOT) for human readable data on a separate panel to the variable data (please see the picture below)?

- Question: Is it possible for the unique identifier of a medicinal product placed on the market in Finland to include a foreign national identification/reimbursement number (NN) even if there is no NN number in Finland?