The Polish pharmaceutical market is one of the largest in the European Union and the rate of sales growth is one of the largest in the EU. Pharmaceutical companies in Poland have felt little or no impact coming from the financial crisis that has hit other economies in Europe. The development of new drugs is also an important factor that keeps these kinds of companies within the fastest growing industries in Poland.
If you want to open a pharmaceutical company in Poland
you should know that this business field is regulated by the Polish Pharmaceutical Law
. Our Polish company formation experts
can give you detailed information about the legal provisions for doing business in the Polish pharmaceutical field
The Pharmaceutical Law in Poland
The Polish Pharmaceutical Law implements a number of directives meant to regulate the distribution, and manufacturing of medicinal products for human use and also about the good clinical practice for investigational medical products for human use. Because Poland is a member of the EU, the country also has to follow special directives and include them into the national legislation.
The main regulatory bodies for pharmaceutical activities in Poland are: the Minister of Health – who supervises other regulatory bodies in the pharmaceutical sector and the Main Pharmaceutical Inspector – who supervises the production of medicinal products and the compliance with the Pharmaceutical Law.
Pharmaceutical companies in Poland
A pharmaceutical company in Poland
will operate as any other company in Poland
, with the special mention that it will need to comply with additional rules and regulations and observe special provisions, according to the type of medicinal products or medical devices it produces. Our Polish company formation experts
can help you open a Polish company and register the legal entity for VAT purposes
will need to obtain special permits and licenses
for functioning in Poland. These permits refer, among others, to marketing authorizations
. According to the Pharmaceutical Law
, any medicinal product that will be commercialized on the Polish market needs to have a national marketing authorization (issued in and valid in Poland) or a European marketing authorization. The competent Polish authority that issues these types of special authorizations is the President of the Office for registration of Medicinal Products
. You can contact our team of specialists for detailed information about obtaining the marketing authorization for medicinal products. Moreover, our team of company formation agents in Poland
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Pharmaceutical companies in Poland need to observe the complete rules and regulations for taxation, annual reporting, as well as tax filing and payment. Our team of accountants in Poland
provides complete solutions for businesses, irrespective of the business field in which they activate. You can reach out to us for bookkeeping, payroll, ledger review, and complete accounting assistance.
Our company incorporation consultants in Poland
can help you invest in the most important cities in Poland. We can give you more information about other Polish business fields like tourism