Investment in pharmaceutical sector in Italy

The export of medical products from Italy

 

The export of medicines abroad is permitted to operators who are authorized to carry out wholesale distribution.

 

The following notes indicate the ways in which a foreign investor can also set up a company in Italy to purchase medicines to resell abroad in its own country or elsewhere.

 

The foreign investor will have to set up a company in Italy with at least one pharmacy graduate resident in Italy, registered in the pharmacists' register in Italy and have at least one employee, manager or partner who holds a degree in pharmacy or chemistry or in pharmaceutical chemistry and technology or in industrial chemistry operating in the structures where distribution and export takes place.

 

The wholesale distribution of medicines is regulated by:

 

- Legislative Decree n. 219/2006 (Drug Code);

 

- Ministerial Decree of 6 July 1999 which contains the rules for correct conservation and transport before sale to the public;

 

- Law n. 248/2006 (Bersani Decree) which introduces the possibility for:

 

• pharmacists who own pharmacies and

• companies of pharmacists who own pharmacies

 

to carry out wholesale distribution of medicines, including the export of medicines abroad.

 

On the basis of this last law, pharmacists and pharmacist companies can purchase medicines directly from the manufacturing companies that makes the subsequent repurchase of them by wholesalers or buyers abroad economically advantageous.

 

The problem of the limitation on exports abroad due to the contractual exclusivity enjoyed by medicines distributors abroad is no longer applicable for generic drugs for which the patent has already expired and the kinds of such medicines produced and available in Italy are many.

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Any activity which consists in procuring, holding, supplying or exporting medicines is considered to be wholesale distribution of medicines (governed by art. 1, paragraph 1, letter r of the Medicines Code), without prejudice to the obligation to supply medicines before to users in Italy.

 

Pursuant to art. 46 Royal Decree n. 1706/1938, and art. 104 of the Medicines Code, wholesalers can sell medicines:

 

- to pharmacies regularly authorized to operate;

 

- to people or companies that have the distribution authorization pursuant to art. 100, paragraph 1, Drug Code.

 

The authorization for the wholesale distribution of medicines is issued by the Regions or the Autonomous Province (Trento and Bolzano) or by other territorial bodies authorized by the Regions, the Local Health Authorities, ASL).

 

The authorization is issued in the presence of the following requirements:

 

- the wholesale distribution activity of medicines on the national territory can only concern medicines for which a Marketing Authorization (AIC) has been issued;

 

- availability of premises, installations and equipment suitable and different from the pharmacy premises and equipment, such as to guarantee good conservation and good distribution of medicines;

 

- presence of adequate staff and a responsible person, in possession of a degree in pharmacy or chemistry or in pharmaceutical chemistry and technology or in industrial chemistry, who has not been criminally convicted for crimes against property or in any case connected to the trade of medicines, nor definitive criminal sentences of at least two years for non-negligent crimes.

 

The person authorized to export medicines must undertake to comply with the following obligations:

 

- make the premises, installations and equipment accessible at all times to the agents responsible for inspecting them;

 

- procure medicines only from people or companies who themselves possess the AIC authorization or who are legitimately exempt from it; this obligation also concerns supplies coming from other EU countries;

 

- if the medicine is procured from the manufacturer or importer, the pharmacy must verify that the manufacturer or importer holds a production authorisation;

 

- if the supply of the medicine takes place through brokerage, the authorized exporter must verify that the broker concerned meets the requirements established by the regulations;

 

- supply medicines only to people, companies or entities that themselves have the authorization for the wholesale distribution of medicines, or are authorized or authorized in another capacity to procure medicines;

 

- ensure that the medicines received are not falsified by checking the labels on the external packaging;

 

- have an emergency plan that ensures withdrawal from the market ordered by AIFA or initiated in cooperation with the manufacturer or holder of the AIC (Marketing Authorisation) of the medicinal product in question;

 

- keep the documentation: invoices, computer or paper files, which contains the data of each entry and exit operation, dates, name of the medicine, quantities received and supplied, batch number, name and address of the supplier or recipient, batch number of outgoing medicines;

 

- keep the aforementioned documentation available to the competent authorities, for inspection purposes, for a period of five years;

 

- those medicines for which there must be availability in minimum quantities cannot be removed from distribution in Italy.