The new regulation adopted in Slovenia implements the labelling requirements set forth in the Commission Delegated Regulations 2016/161/EC supplementing Directive 2001/83/EC. The regulation provides detailed rules on the packaging of medicinal products and medical devices for human use. The aforementioned documents regulates the way medicinal products intended for human use should be packaged.
The Scope of the Regulation
The competent authority responsible for the enforcement of the regulation is the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP), Slovenia`s national authority in the sphere of medicinal products circulation.
According to the Directive, unique identifiers were implemented to prevent the possibility of any interference in the medicinal products supply chains and also to counter the distribution of falsified medicinal products to prevent harm to patients` health that could be caused by such products. For this purpose, all medicinal products and medical devices available at the EU market should have appropriate packaging to identify the device and confirm its authenticity. At the same time, it is important that any additional requirements should lead to delays or in any other way make difficult for manufacturers to place their devices at the market. That is why the rules had been introduced on the international level to reduce the impact of discrepancies between regulatory frameworks implemented in different countries. Such an approach also guarantees that a similar protection level would be maintained within the whole territory of the European Union.
Each product and device receives an identifier containing a product code, identification number, batch number, and expiry date. To prevent falsification, the serial number should be generated in accordance with randomization rules. Special human-readable format of printing allows using identifiers even in case if two-dimensional barcode could not be recognized by the system. At the same time, the packaging should bear only one barcode containing all necessary information to avoid mistakes.
The procedure includes several consecutive steps.
- The packaging of the medicinal product should be equipped with a unique identifier simultaneously with the uploading of the information on the particular identifier assigned to the product to the global database.
- The validity of identifiers should be verified before providing the products to end-users.
- Any party should inform authorized bodies in case of any issues detected related to the validity of the identifier.
In the case of high-risk devices, their authenticity should be also confirmed by wholesalers during intermediary steps within the supply chain.
The verification procedure itself constitutes a comparison of the identifier placed on the packaging of the medicinal product with the appropriate identifier uploaded to the database.
It is also important to mention that in case if the medicinal product subject to export outside the EU or is being provided to the end-user, the identifier should be deactivated to prevent its unauthorized use.
The regulation sets forth the rules related to operations with identifiers, obligatory for wholesalers, persons responsible for the distribution of medicinal products (including the distribution by healthcare facilities) or provision to the entities and organizations, and also for any persons authorized to make changes to the online databases and registers (archives) containing information on identifiers.
New Packaging Requirements
According to the regulation, the wholesaler shall check the packaging and remove the identifiers before providing medicinal products to the following categories of customers:
- Veterinary facilities subject to the appropriate regulation,
- Armed forces,
- Ministry of internal affairs,
- Inventory reserve institute,
- Educational institutions,
- Social care institutions.
At the same time, one providing the medicinal product directly to patients being an official person of the healthcare facility should not remove the identifiers.
The regulation also provides a set of requirements related to medicinal products register maintenance. According to such requirements, the entity operating the register should implement measures preventing from placing to the market and providing to the patients’ medicinal product that had been marked as “counterfeit” or “subject to withdrawal”, or in case if the identifier has been removed or its term has expired.
There are two main goals of authentication:
- To confirm that the product had been produced by the particular manufacturer as stated in the documentation provided with the product, and
- To confirm that the packaging had not been opened, so its content remains authentic.
That is why it is important to ensure that all information used for comparison could be uploaded to the database only by authorized persons.
The regulation also provides a list of prohibited actions subject to punishment in the form of financial sanctions (fines payable by the entity that committed such actions). The list includes such elements as:
- Issuing packaging without an identifier,
- Providing medicinal products without removing the identifier in case if it is prescribed by the regulation,
- Intervention in the performance of the database (archive) in a way that impacts its operations or unauthorized alteration of data contained therein,
- Printing with the quality lower than required in applicable regulations,
- Failing to print necessary elements in the form that simplify its reading and perception,
- Placing additional codes instead or together with ones required by regulation,
- Distribution of a product bearing identifier that has been deactivated and thus no longer valid,
- Restoring the status of a deactivated identifier to make it active again,
- Failing to check the code or to enter the information to the internal register,
- Failing to take actions necessary in case of reasonable suspicions that the packaging, labeling, identifier or the product itself constitutes counterfeit,
- Failing to perform any obligation to provide only part of the packaging to the end-user.
According to the regulation, anyone who has reasonable suspicions that the medicinal product is counterfeit or if particular details of packaging and/or identifier, shall immediately suspend the provision of such medicinal product and notify state authorities.
The effectiveness of the medicinal products tracking system based on the utilization of identifiers depends on the way the information on identifiers being entered into the database. That is why the regulation contains a set of rules regulating all procedures concerning operations with information stored in registers, including entering information and amending it. The regulation also introduces fines for any actions that impact the correct operations of the databases. For example, it is strictly prohibited to refuse in providing access to information stored in a database when a provision of such access is prescribed by applicable regulations. Other prohibited actions include failure to comply with the rules on making changes to the registers. Any changes made to the information stored in the system should be performed in accordance with the procedural rules set forth by applicable regulation.
Depending on particular action committed, fine should be paid by a sole proprietor or responsible person of the legal entity.
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