Updated European Commission Questions & Answers document, version 13, "Safety Features for Medical Products for Human Use"

The European Commission Q & A version 13 can be downloaded: https://ec.europa.eu/health/sites/health/files/files/falsified_medicine…

In particular, please note the following new Q&As in the latest version:

1.24. Question: In some cases a medicinal product may carry more than one batch number, typically when the product consists of an active component and a solvent. Which batch number(s) should be encoded in the medicines verification system in that case?

Answer: Only the batch number of the active substance needs to be encoded in the medicines verification system.

1.25. Question: When repackaging or re-labelling a pack for the purpose of using it as authorised investigational medicinal product or authorised auxiliary medicinal product according to Article 16(2) of Commission Delegated Regulation (EU) 2016/161, the unique identifier should be decommissioned. What status of decommissioning should the pack have?

Answer: Until there is a specific status for these medicines in the EMVS system, the pack should be decommissioned as “SUPPLIED” when repackaging or re-labelling for use as an authorised investigational medicinal product or authorised auxiliary medicinal product.

1.26. Question: During the transitional period, do manufacturers located in the EU/EEA need to place safety features on medicines intended for the Greek or Italian market?

Answer: No. Greece and Italy have decided to defer the entry into application of the safety features in line with Article 2(2)(b) of Directive 2011/62/EU. Medicines produced exclusively for the Greek or Italian market, regardless of their place of manufacture, are therefore not required to bear safety features before the entry into application of the new rules in Greece or Italy.

1.27. Question: During the transitional period, can manufacturers located in Greece or Italy place unique identifiers on medicines intended for the rest of the EU/EEA? What about uploading data to the EU hub?

Answer: Yes. There are no geographic restrictions on the placing of safety features by manufacturers. Please see Q&A 7.19 regarding data upload. 10

1.28. Question: Is there an obligation for direct suppliers to healthcare institutions to offer aggregation services?

Answer: No. The Delegated Regulation does not require hospital suppliers to provide aggregation services. Suppliers may however offer the service on a voluntary basis, providing the safeguards outlined in the Expert Group paper on implementation of the Falsified Medicines Directive in the hospital setting3 are met.

2.22. Question: Do human-readable headers (PC, SN, Lot, EXP, NN) have to comply with the provisions of the QRD-template?

Answer: Yes, preferably. According to version 10 of the QRD-template4 , the product code, serial number and national reimbursement number in the human readable code should be preceded by the letters “PC”, “SN” and “NN”. Batch number and expiry date should follow the abbreviations laid out in Appendix IV of the QRD-template5 .

3.6. Question: Can a medicine with only one of the safety features (either the UI or ATD) that has been released for sale before 9 February 2019 remain on the market?

Answer: Yes, a medicine with either a UI or ATD that has been released for sale before 9 February 2019 and has not been repackaged or re-labelled may remain on the market until its expiry date.

4.5. Question: Are manufacturers responsible for ensuring unique identifiers are readable and complete?

Answer: Yes. Manufacturers must check that the 2D barcode is readable and contains the correct information (Article 14 of Commission Delegated Regulation (EU) 2016/161). Furthermore, manufacturers must work closely with marketing authorisation holders to ensure that all relevant information on unique identifiers has been uploaded to the repository system before they release medicines for sale or distribution (Article 33(2) of Commission Delegated Regulation (EU) 2016/161).

8.9. Question: Should marketing authorisation holders upload the unique identifiers for products with 2D barcodes released for sale or distribution before 9 February 2019?

Answer: Yes. According to Article 48 of Commission Delegated Regulation (EU) 2016/161, medicines released for sale or distribution before 9 February 2019 without a unique identifier may remain on the EU market until their expiry date, as long as they are not repackaged or relabelled after that date. This transitional measure does not apply for products which were released before 9 February 2019 with a unique identifier. The unique identifiers for such products should be uploaded to the system before the entry into application of the new rules (9 February 2019). This should help to avoid alerts for genuine products released before 9 February due to lack of data in the repository.

Please also note the revised Q&A in the latest version:

5.7. Question: Is wholesale distribution of medicinal products with a damaged/unreadable 2D Data Matrix code allowed, if there is no suspicion of falsification?

Answer: It depends on the human readable code. If the verification of the authenticity of the unique identifier (UI) can be performed using the human readable code, the product can be further distributed. If the verification of the authenticity of the UI cannot be performed (because the human readable code is damaged or absent), then the wholesaler should not further distribute the product with unreadable codes (Article 24 of Regulation No 2016/161). This requirement is independent of whether the verification was mandatory under Article 20 of Commission Delegated Regulation (EU) 2016/161 or voluntarily performed by wholesalers.