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Open a Pharmaceutical Company in Italy

Updated on Thursday 14th April 2016

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Italy is an important pharmaceutical manufacturer and national and multinational pharmaceutical companies work in this field to produce pharmaceutical products and medicines. The Italian pharmaceutical industry has shown a trend for development in recent years and more foreign investors open pharmaceutical companies in Italy.
 
Important international pharmaceutical producers have also opened branches or subsidiaries in Italy. Because Italy does not have its own large multinational companies in this business field, the market is dominated by large international companies and smaller Italian companies.
 
Our company formation agents in Italy can help you get started and obtain all the necessary permits and licenses for functioning if you want to open a company in the pharmaceutical field.
 

The pharmaceutical industry in Italy

 
The pharmaceutical industry in Italy produces medicines and medical devices that are either distributed nationally or exported to other countries. Italian pharmaceutical products are usually exported to countries like: Belgium, Germany, the United Kingdom, Switzerland and USA.
 
Medicines manufactured in Italy include:
 
- oral medicines,
- injection medicines,
- ophthalmic and ontological products,
- creams,
- sprays,
- gels.
 
The packaging for these products varies according to the type of product and manufacturers need to observe special rules and regulations for packaging.
 

A pharmaceutical company in Italy

 
Like any other company in Italy, pharmaceutical companies need to be incorporated and registered at the relevant tax authorities. Pharmaceutical products are also subject to VAT in Italy.
 
The relevant Italian authority for dealing with issues regarding the production and manufacturing of pharmaceutical products is the Italian Medicines Agency. The agency observes the European laws for medicinal products registration and it is responsible for the registration of any medicinal products in Italy.
 
Two methods of registration are available - a national procedure and a community procedure. The national procedure allows the firm to obtain a marketing authorization only within Italy’s territory, while the community registration allows for recognition of the product to one or more EU member states.
 
Any human use medicines must go through the marketing authorization procedure. These products include biological medicines, radiopharmaceuticals, medicinal gasses, herbals and homeopathic medicinal products.
 
The Italian Medicines Agency is also responsible for pharmacovigilance in Italy. It monitors all newly marketed drugs and medicines for which important changes to the marketing authorization have been made.
 
The owner of a pharmaceutical company in Italy will also have to comply with the EU Good Manufacturing Practice and the related guidelines.
 
Our company formation agents in Italy can give you more information about the legislation for investments and how to invest in other business sectors in Italy. You can contact us you have any questions.
 
 

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