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Set Up a Pharmaceutical Company in Malta

Set Up a Pharmaceutical Company in Malta

Pharmaceutical companies fall under the regulations of the Maltese Medicines Act of 2003 and pharmacy licenses are issued according to the Subsidiary Legislation 458.16. In order to open a pharmacy in Malta, the premises must first undergo an inspection from the Inspectorate and Enforcement Directorate of the Medicines Authority. A Maltese company selling pharmaceutical products is subject to five types of inspections:

  • – for new applications,
  • – for follow-up,
  • – for renewal,
  • – for variation,
  • – spot check inspections.

Also, in order to manufacture pharmaceutical products, the correct NACE code from the Nomenclature of Economic Activities must be selected:

  • – DG 24.4 for manufacturing pharmaceuticals, medicinal chemicals and botanical products,
  • – DG 24.41 for manufacturing basic pharmaceutical products,
  • – DG 24.42 for manufacturing pharmaceutical preparations.

For the retail of pharmaceutical products, a Maltese company must select the G 52.3 for the retail of pharmaceutical and medical goods, cosmetic and toilet articles in the Nomenclature.

Our Maltese agents in company formation will guide you through the registration procedure.

What are the licensed pharmaceutical activities in Malta?

Pharmaceutical companies in Malta may apply for various licenses depending on the activities they will carry out. The following certificates may be issued for a Maltese pharmaceutical company:

  • – a good manufacturing practice certificate,
  • – a manufacturing license,
  • – a wholesalers license,
  • – a registered active pharmaceutical ingredients (API) importer and wholesale distributor license.

Maltese pharmacies may also act as registered brokers of medical products for human use.

What are the documents to be submitted when applying for a pharmacy license in Malta?

Pharmaceutical companies in Malta are required to submit the following documentation when filing for a pharmacy license:

  • – a prescribed application form,
  • – a declaration of the managing pharmacist,
  • – a clean criminal record issued by the police for the pharmacist license holder,
  • – a plan of the premises with the total surface area endorsed by the declaration of an architect,
  • – a detailed description of the pharmacy premises.

Maltese companies opening pharmacies are also required to submit the articles of association of the company issued by the Malta Financial Services Authority.

For complete information about pharmaceutical licensing requirements, please contact our company incorporation agents in Malta.