The European regulations provide for that companies intending to market medicinal products, food supplements, medical devices, cosmetics, PMC (presidi medico chirurgici, medical surgical aids), biocides in the European Union should be located in a Member State. Alternatively, based on the product category, they could avail themselves of a representative located in a Member State or open a branch in the EU.
Di Renzo Regulatory Affairs has recently started a new consultancy option for foreign companies wishing to open a branch in the EU or in Italy. This opportunity could be of interest for companies involved in the aftermath of Brexit, in search of a new location in the European union.
Di Renzo Regulatory Affairs is therefore able to offer the following.
- Starting all legal, notary, administrative and tax procedures to obtain the company certificates required to operate in Italy and in other countries of the European Union
- Examination of the company project in order to identify the best type of company to be activated
- Contacts with national and international logistics for the distribution of products in Italy and in other countries
- Possible cooperation for the identification of companies that can represent the foreign company in Italy
- Drafting, together with its experts, of an overview of the national business situation in the sector of medicinal products
- Taking on the role of Applicant for the registration on medicinal products in Italy and other EU countries.