OBJAVLJEN AŽURIRANI EU Q&A DOKUMENT ZA SERIJALIZACIJU

Iako serijalizacija lijekova više nije tako nova tema, na razini EU se i dalje povremeno ažurira Q&A dokument vezan za serijalizaciju pa je tako nedavno objavljena 21. verzija. U nastavku donosimo 4 pitanja na koje se odnosi ovo zadnje ažuriranje te pripadajuće odgovore.

1.1. 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 placed; and

(2) a device allowing the verification of whether the packaging of the medicinal product has been tampered with (anti-tampering device).

1.20. Question: If a pack bearing the safety features is lawfully opened (e.g. by parallel traders/manufacturers replacing the leaflet under the supervision of national competent authorities), can it be resealed (e.g. by applying a new ATD on top of the old, broken ATD)?

Answer: Yes, such package can be resealed (e.g. by applying a new ATD on top of the original, broken ATD) provided the requirements in Article 47a (1) of Directive 2001/83/EC are fulfilled.

This implies that:

(a) the authenticity of the unique identifier and the integrity of the ATD on the original pack were verified as authentic before breaking the original ATD/pack.

(b) the replacement of the ATD is conducted in accordance with applicable Good Manufacturing Practice principles and is subject to supervision by the competent authority.

(c) the replacement ATD must make it possible to verify, with the same effectiveness as an original ATD, that the outer packaging of a medicinal product has not been unlawfully opened - tampered with - between the time at which that medicinal product is repackaged and that at which it is supplied to the public. This assumes that it is evident for everybody that a new ATD has been placed and by whom. The latter implies that the repackager of the medicinal product must be clearly stated on the outer packaging.

1.21. Question: Is it possible for manufacturers/wholesales/parallel traders to market/supply medicinal products with a packaging showing visible signs of opening/intrusion, but where the ATD has been replaced by a new ATD in accordance with Article 47a of Directive 2001/83/EC?

Answer: Yes, this is possible if the presence of visible signs of opening on the packaging are consistent with legal repackaging of that medicinal product by a parallel importer or by a parallel distributor.

It should be noted that Articles 24 and 30 of Commission Delegated Regulation (EU) 2016/161 prohibit wholesalers and persons authorised or entitled to supply medicinal products to the public who receive a medicinal product having a packaging showing signs of tampering from supplying that product. So they must be free of doubt that traces of opening are attributable to the repackaging

2.21. Question: Is it acceptable to use stickers to place the unique identifier on the outer/immediate packaging?

Answer: As a rule the unique identifier must be printed on the packaging (Article 5(3) of Commission Delegated Regulation (EU) 2016/161).

For medicinal products subject to parallel import and parallel distribution it is possible to use a sticker (adhesive label) provided that the sticker cannot be removed without being damaged and that the sticker fulfils the quality of the printing requirements set out in Article 6 of the Commission Delegated Regulation (EU) 2016/161 (case C‑147/20, Novartis Pharma GmbH v Abacus Medicine A/S).

The replacement of the unique identifier must be conducted in accordance with applicable Good Manufacturing Practice principles. Moreover all applicable labelling requirements in Directive 2001/83/EC must be met and the sticker must not impair the readability of other required labelling elements.

Sva pitanja i odgovore pogledajte u Q&A dokumentu za serijalizaciju.