Q&A – Official Directives from European Parliament

QUESTION: What are the safety features?

Answer: The safety features consist of two elements placed on the packaging of a medicinal product: (1) a unique identifier, a unique sequence carried by a two-dimensional barcode allowing the identification and authentication of the individual pack on which it is printed; and (2) a device allowing the verification of whether the packaging of the medicinal product has been tampered with (anti-tampering device). 

QUESTION: When do the rules on the safety features apply?

Answer: They apply as of 9th February 2019. Belgium, Greece and Italy have the option of deferring the application of the rules by an additional period of up to 6 years. 

 

QUESTION: Do the safety features need to be applied on all medicinal products for human use?

 Answer: No. The safety features should only be applied on the packaging of the following medicinal products for human use: (1) medicinal products subject to prescription which are not included in the list set out in Annex I to of Regulation (EU) No 2016/161; (2) medicinal products not subject to prescription included in the list set out in Annex II of Regulation (EU) No 2016/161. (3) medicinal products to which Member States have extended the scope of the unique identifier or the anti-tampering device to in accordance with Article 54a(5) of Directive 2001/83/EC. 

QUESTION: Once regulation (eu) no 2016/161 applies, can manufacturers place the safety features, on a voluntary basis, on medicinal products not required to bear the safety features?

Answer: No. Once Regulation (EU) No 2016/161 applies, manufacturers cannot place the safety features on medicinal products not required to bear the safety features, unless the Member States have extended the scope of application of the unique identifier or of the anti-tampering device to those medicinal products in accordance with Article 54a(5) of Directive 2001/83/EC.

QUESTION: Certain medicinal products are currently bearing an antitampering device on a voluntary basis. Are those products allowed to maintain the anti-tampering device once regulation (eu) no 2016/161 applies, if they are not required to bear the safety features?

Answer: Once Regulation (EU) No 2016/161 applies, medicinal products can only bear an anti-tampering device if they are in the scope of Article 54a(1) of Directive 2001/83/EC (i.e. if they are medicinal products subject to prescription or medicinal products listed in Annex II of Regulation (EU) No 2016/161) or if the Member State(s) where they are placed on the

QUESTION: Would it be possible to include, on a voluntary basis, a twodimensional barcode on the packaging of medicinal products for human use not having to bear the safety features if the information carried by the barcode does not serve the purposes of identification and authentication of the medicinal product and does not include a unique identifier?

Answer: Yes, provided that the relevant labelling provisions of Title V of Directive 20014/83/EC are complied with. Examples may include two-dimensional barcodes encoding price indications, reimbursement conditions, etc. 

QUESTION: Are there any mandatory specifications for the antitampering device?

Answer: In accordance with Article 54(o) of Directive 2001/83/EC and Article 3(2)(2) of Regulation (EU) No 2016/161, an anti-tampering device has to allow the verification of whether the packaging of the medicinal product has been tampered with. There are no other mandatory specifications. The CEN standard EN 16679:2014 “Tamper verification features for medicinal product packaging” is available for manufacturers to consider. 

 

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