Running a pharmaceutical wholesale business is a strictly regulated activity, subject to exceptionally detailed legal requirements. Obtaining the appropriate licence is a difficult task in itself. Unfortunately, there are a number of situations where market participants can lose such a licence very quickly. We outline the conditions for undertaking this activity and the circumstances under which the GIF may (or must) revoke a licence.
💡 Key takeaways
- Revocation of a permit by the Chief Pharmaceutical Inspectorate (GIF) can occur for mandatory reasons (they must result in loss of rights) and optional reasons (they depend on the scale of the transgression).
- The export of scarce medicines abroad without the consent of the GIF or the trading of products not permitted for circulation are the quickest routes to the mandatory loss of authorisation.
- The loss of authorisation means for the entrepreneur three-year ban to apply for a new wholesale or pharmacy licence. Furthermore, the GIF may withdraw licences for the same reason all Wholesalers belonging to the same entrepreneur.
Often, due to stress, business owners obstruct inspections by officials. Meanwhile, regardless of any shortcomings found during an inspection, the best defence against losing a permit is full cooperation with PIF authorities. It is easier to reverse the consequences of failings than to revoke a GIF decision issued due to the withholding of documents.
Pharmaceutical wholesaler in GIF's sights. What can lead to the loss of a licence?
How to obtain a permit to run a pharmaceutical wholesale store?
Running a pharmaceutical wholesale business requires obtaining a permit from the Chief Pharmaceutical Inspector (Article 74(1) of the Pharmaceutical Law). This procedure is application-based and involves a fee (approximately PLN 6756). Granting the permit is an administrative decision, and failure to meet the strict requirements concerning premises, personnel, and procedures will result in immediate refusal.
Crucially, when planning the wholesale trade of narcotic drugs or psychotropic substances (e.g. Category 1 precursors), an entrepreneur must obtain a separate, independent permit under the regulations on combating drug addiction.
Loss of permit – legal grounds
The grounds for revoking a permit (Art. 81 and Art. 37ap of the Pharmaceutical Law) are divided into mandatory (GIF music (issue a decision to withdraw) and optional (GIF Perhaps to issue a decision, depending on the severity of the violations).
Mandatory grounds for withdrawal of a permit
Among the hard premises absolutely forcing the revocation of the permit are, among others:
- Trading in medicinal products not permitted for trading in the territory of the Republic of Poland.
- Exporting products from the so-called "export ban list" (deficiency medicines) abroad without prior notification to the GIF or before the expiry of the 30-day period for objection by the Chief Inspectorate.
- Failure to rectify irregularities identified in an post-inspection decision within the specified deadline.
- Failure to meet legal requirements for conducting the activity specified in the permit (a very general and dangerous premise for the entrepreneur).
Optional grounds for withdrawing the permit
Soft prerequisites depend on the assessment of the scale of shortcomings. These include, among others:
- Obstruction or prevention of control activities by inspectors of the State Pharmaceutical Inspectorate (PIF).
- Storage of products not in accordance with Good Distribution Practice (e.g. incorrect temperature conditions).
- Failure to commence operations within 4 months of obtaining consent, or a break in operations lasting 6 months.
- Failure to ensure continuity of supply of reimbursed medicines to pharmacies (so-called prioritisation of exports over the Polish domestic market).
Domino of sanctions: 3-year ban and closure of the entire network
In cases of serious violations (e.g. dealing in illegal drugs), the law gives the Inspector a devastating weapon: the GIF can revoke permits with regard to all other pharmaceutical wholesalers belonging to a given undertaking..., even if the breach only occurred in one branch.
To make matters worse, the loss of a permit results in a 3-year ban (grace period) from applying for another permit to run any pharmaceutical wholesaler or pharmacy in Poland.
What should be paid particular attention to in practice?
The regulatory bodies are most aggressively prosecuting those involved in what is referred to as pharmaceutical mafia and illegal export of medicines From Poland. Deficient medicines are often more expensive in the West, which tempts wholesalers to export, to the detriment of Polish patients. Conducting such operations without formal consent and monitoring would certainly lead to the revocation of licences.
Attention should also be paid to the concept of turnover – it is not just sales, but also storage places with expired market authorisations or recalled defective batches. This requires a functional IT system integrated with GIF messages.