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Chief Pharmaceutical Inspectorate

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Safe medicine, safe purchase

Sold in Poland can only be those medicinal products that have received marketing authorisation issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products or by the Council of Europe or the European Commission. Each medicinal product must undergo a registration process, which involves the assessment of the safety, quality, and efficacy of the medicine. It means that both the efficacy and the safety of the medicine must be confirmed. Assessed as part of the registration process are informational documents, such as Summary of Product Characteristics, Package Leaflet, and package labelling – they constitute an integral part of the marketing authorisation of each medicinal product.

The secondary packaging of a medicinal product – if the product does not have secondary packaging, then its primary packaging – should contain the following information:

  1. In the following order:
  •  Name of the medicinal product and international non-proprietary name of the active substance(s);
  • Strength of the medicinal product; 
  • Specification of the pharmaceutical form;
  • Information whether the product is intended for infants, children, or adults, if applicable;
  • Specification of the package size – with weight, volume, or number of dosage units of the medicinal product.
  1. The qualitative and quantitative content of the active substances per a dosage, volume, or weight unit, using international non-proprietary names.
  2. List of excipients with recognised effects specified based on Article 65 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67, as amended; Official Journal of the European Union, Special Polish Edition, chapter 13, volume 27, p. 69, as amended), while for medicinal products used parenterally, topically, or applied to the eyes – list of all the excipients.
  3. Use and, if necessary, route of administration.
  4. Warning that the medicinal product must be stored out of the sight and reach of children.
  5. Warnings relating to the place and method of storage if applicable.
  6. Other special warnings if necessary.
  7. Availability category, referred to in Article 23a(1) of the Pharmaceutical Law Act of 6 September 2001, hereinafter referred to as “the Act.”
  8. Expiry date (month and year), while for proprietary medicinal products which require special actions right before their use – also when it is necessary due to the properties of the medicinal product – specification of the shelf life after reconstitution of the medicinal product.
  9. Special precautions to be followed when disposing of unused medicinal products or waste materials derived from such medicinal products, if appropriate.
  10. Name and address of the marketing authorisation holder and, if applicable, name and address of the representative of the marketing authorisation holder.
  11. Marketing authorization number.
  12. Lot number.
  13. Instructions for use if the medicinal product is not subject to medical prescription.
  14. EAN UCC barcode.

 

The package leaflet must contain all information related to the safe and effective medicine action. The package leaflet is addressed to the patient.

The list of medicines with marketing authorisation is available at:
https://pub.rejestrymedyczne.csioz.gov.pl/

Prescription medicines are to be bought at facilities authorised to market medicinal products:

  • retail pharmacies;
  • limited service pharmacies.

Furthermore, there are groups of medicinal products approved for non-pharmacy sale, which are specifically listed in the Regulation of the Minister of Health of 22 October 2010 on the List of Medicinal Products That Can Be Approved for Sale at Non-pharmacy Outlets and Limited Service Pharmacies (Journal of Laws 2010.204.1353). The said medicines can be purchased at limited service pharmacies, herbalist shops, retail stores, and specialist medical supplies shops.

Legal medicines sale over the Internet

Retail pharmacies and limited service pharmacies operating based on a licence issued by a voivodeship pharmaceutical inspector can run mail-order sale of medicines not subject to medical prescription. At the homepage of a pharmacy operating mail-order sale, there should be information available that identifies the business (registered office, company name, pharmacy address, contact telephone) and data relating to the licence to run a pharmacy. The information should be provided in a clear and unambiguous manner. The list of legally operating online pharmacies can be found at: https://rejestrymedyczne.csioz.gov.pl/ra/

REMEMBER – ONLY OVER-THE-COUNTER MEDICINES CAN BE SOLD OVER THE INTERNET.

Immediate reaction – patient

Everyone who reasonably suspects to have come into possession of a falsified medicine, should, first of all, seek advice from:

  • the pharmacist at the nearest pharmacy;
  • the primary care physician.

Then, after confirming the suspicion, the police or the state pharmaceutical inspection must be notified.

REMEMBER, YOU CAN PROTECT YOURSELF AND OTHERS.

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