The new law implementing the EU rules on falsified medicines which has been applicable since February 2019 (Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use – ‟EU Regulationˮ) will enter into force on 23 October 2019. This new law was introduced through an amendment to the Pharmaceutical Law, of which the main elements have been described below.
1. Change of identifier
The references to the EAN UCC have been replaced in the Pharmaceutical Law (and other applicable laws) by references to the GTIN (Global Trade Item Number).
2. Competent authority for falsified medicines
The pharmaceutical inspection will be responsible for the supervision of compliance with the obligations set out in the EU Regulation, for instance, it will supervise whether the manufacturer has placed a unique identifier on the packaging of its medicinal product in accordance with the technical specifications determined in the EU Regulation.
The Polish Chief Pharmaceutical Inspectorate (PL: Główny Inspektorat Farmaceutyczny, ‟GIFˮ) will supervise the functioning of repositories with unique identifiers located in Poland. The GIF will also supervise the marketing authorization holders (‟MAHˮ), manufacturers, importers, and wholesalers with respect to:
- the verification of the authenticity of a unique identifier,
- the decommissioning of a unique identifier,
- the correctness of the uploaded data and performed operations in the national repositories system.
3. New obligations for wholesalers
The new law allows for the possibility for a MAH to designate a wholesaler, by means of a written contract, to store and distribute products covered by its marketing authorisation on its behalf. This possibility is connected with the wholesaler’s new obligation to provide the GIF with a copy of the contract (without information concerning the financing) within seven days after the contract’s conclusion. If this contract had already been concluded between a wholesaler and a MAH before the new law entered into force, its copy (without information concerning the financing) would have to be provided to the GIF by 22 November 2019.
Moreover, as of 1 July 2020, a wholesaler would not be allowed to subcontract the activities determined in this contract with a MAH.
The Polish government decided to take advantage of the possibility given in the EU Regulation to oblige wholesalers to verify the safety features and to decommission the unique identifier of a medicinal product before it is supplied to various persons or institutions. The new law contains an enumerative list of all applicable categories; for instance physicians, nurses, veterinary facilities, and universities.
If the wholesaler does not comply with the above obligations, the GIF would be able to revoke its permit to run a pharmaceutical warehouse.
4. Financial penalties – Entering into force on 1 July 2020
The non-compliance of a MAH, manufacturer, importer, or wholesaler with its respective new obligations would be subject to a financial penalty of up to PLN 500,000 (approximately EUR 120,000). The penalty would be imposed by the GIF.
5. Extended scope
The new Polish law gives MAHs the possibility to decide whether to place anti-tampering devices on the packaging of their medicinal products which have been:
- included in the list set out in Annex I to the EU Regulation, or
- not subject to prescription and not included in the list set out in Annex II to the EU Regulation.
The placing of anti-tampering devices is not obligatory on the packaging of these medicinal products under the EU Regulation.
We advise verifying whether the packaging and all internal procedures in Poland are in compliance with the EU Regulation. Companies have time until 1 July 2020 to introduce all the necessary changes in order to avoid penalties.
A MAH’s contracts with wholesalers should also be verified. Certain contracts will be partially disclosed to the GIF, therefore, amendments to existing contracts or the conclusions of new contracts might be necessary.
Lastly, wholesalers (including many manufacturers, MAHs, and distributors which have their own pharmaceutical warehouses) should verify their business scheme and their capability of complying with the new obligations. If, at the moment, a number of their activities are conducted by subcontractors, this might need to cease on 1 July 2020 at the latest with respect to the activities determined in the written contracts to store and distribute products covered by the marketing authorisation on behalf of a MAH.