On 29 July 2014, the Polish Council of Ministers approved the draft Act transposing Directive 2011/62/EU of the European Parliament and of the Council dated 8 June 2011, amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of entry into the legal supply chain of falsified medicinal products.
Although Member States were obliged to transpose the Directive by January 2013 at the latest, the draft Act is expected to be adopted by the Polish Parliament in the near future. The bill comprises approximately 60 pages of new provisions and the Minister of Health has already prepared 17 drafts of executive acts.
The draft Act sets forth new measures in pharmaceutical law aimed at protecting consumers against falsified medicinal products. Such measures include restrictions on carrying out business, such as new registers, new regulated professions, additional burdens and inspections. The increased number of inspections and registration duties are designed to decrease the possibility of falsified medicines entering into trade channels.
We summarise below the key new regulations that would be introduced into Polish Pharmaceutical law once the bill is adopted:
Manufacturing, importing and distributing APIs (Active Pharmaceutical Ingredients) will constitute a regulated business activity and thus require recording in a new register. However, contrary to manufacturing medicines, the manufacture of APIs will not require public authorization. An API manufacturer will have to, inter alia, submit an affidavit in accordance with criminal liability stating that it conducts its business according to obligations under Pharmaceutical Law and its implementing acts. Manufacturers, importers and distributors of APIs and excipients will also be subject to GIF (General Pharmaceutical Inspectorate) inspections. Manufacturers and distributors may also request an inspection in order to obtain GMP (good manufacturing practice) and GDP (good distribution practice) certificates. The costs of such requested inspections are to be borne by the applicant. Importers will be entitled to import APIs from third countries (outside the EEA) for which a relevant authority of that third country has issued written confirmation that the API manufacturing plant meets certain standards (exceptions are listed in art. 46B sec. 3 and 4 of the Directive).
Brokering of medicinal products (save for veterinary products) will be a regulated profession, i.e., brokers will have to meet certain legal requirements and be registered. Other entities involved in a pharmaceutical products' distribution chain may only cooperate with registered brokers. Brokers will also be subject to GIF inspections. This means that trading in pharmaceuticals will become controlled at each level of distribution.
Online pharmacies selling OTC medicines to the public will be obliged to notify this activity in order that the new activity is recorded on the National Register of Public Pharmacies. Pharmacies should adjust their premises to meet the new requirements, such as having separate places for preparation, packing and sending medicines ordered online. If online sales of medicinal products are not reported to the authorities, a permit for operating a pharmacy may be withdrawn.
Wholesalers will be obliged to inform public authorities about any change in their activities, including change of address, company name etc. If they do not comply, the wholesalers' permit to conduct wholesale trade may be withdrawn. The GIF will conduct an inspection every three years to determine whether the wholesale of medicines complies with statutory requirements. If the GIF suspects that the wholesale of medicines constitutes a threat to the safety, quality and efficacy in using medicines, it may commence an interim inspection. Wholesalers will also be obliged to keep all records of purchases and sales of medicines.
Manufacturing and importing medicinal products by marketing authorisation holders, manufacturers and importers of medicinal products will be additionally controlled by the GIF. Copies of contracts on manufacture or import of medicinal products will have to be provided to the GIF.
Once the draft Act transposing the Directive enters into force, manufacturers, importers and distributors of APIs will have three months to apply for entry into the new register. However brokers in medicinal products and online pharmacies will have much less time to comply with the new regulations. Brokers in medicinal products transactions will have 14 days to apply for registration. Pharmacies will also have 14 days to report medicinal product distance sales to the relevant Regional Pharmaceutical Inspector (WIF).
In practice it seems that the GIF has already implemented a much stricter policy aimed at preventing trade in falsified medicinal products. The GIF is conducting more inspections and frequently imposes fines for unregistered trade in medicines or falsified medicinal products.