A distributor of medicinal products sources the products he distributes from within the EU/EEA. They are required to follow good practice guidelines known as Good Distribution Practice (GDP) in order to ensure that the quality of the medicinal products is not compromised in the supply chain and in order to be in a position to carry out a recall of any defective product.
The Medicines Authority regulates wholesale distributors of medicinal products for human use. It carries out inspections to ensure that their activities are in compliance with legislation and with EU GDP guidelines.
Inspections are held at the licensed sites and the activities performed since the previous inspection are reviewed. Proposed sites for new licences are also inspected and lists of works issued.
The licensed organisation is issued with a list of findings after the inspection, to which they are required to respond with firm proposals for corrective actions within 28 days. Once all findings have been appropriately addressed with an acceptable corrective action plan and measures, the renewal of the wholesale dealer's licence is recommended to the Licensing Authority, which is the body responsible for issuing licences. Re-inspection of sites is performed at a frequency determined through a systematic risk-based assessment.
A wholesale dealer's license is required in order to trade in medicinal products. The wholesale dealer is required to source medicinal products from licensed entities and only to sell or distribute to other licensed wholesale dealers and pharmacies. A medicinal product being placed on the market must be authorised. Each batch must also be released by a Qualified Person. A wholesale dealer's license only authorises the wholesale dealer to trade in or hold medicinal products which have been purchased or otherwise obtained from a licensed manufacturer or wholesale dealer site situated within the EU/EEA. Export of medicinal products also falls within the scope of a wholesale dealer's licence.
The wholesale dealer is required to ensure that the medicinal product is stored in line with the storage conditions provided by the manufacturer. He is also expected to have reasonable measures in place to ensure the security of the medicinal product and to avoid counterfeit or falsified products from entering the supply chain.
Wholesale dealers are also responsible for performing any recalls of medicinal products they have distributed. An effective system to carry out such recalls must be in place.
Every licensed wholesale dealer must appoint a Responsible Person who is ultimately responsible for ensuring that an effective quality system is in place. In Malta this person must be a pharmacist registered with the Pharmacy Council.
Brokers, that is to say persons or companies involved in brokering activities for medicinal products for human use, are required by legislation to notify their activity through the submission of a registration application with the Medicines Authority. Brokering activities are defined in the Directive 2001/83/EC as amended and in the national legislations as:
‘All activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person.'
In simple words brokering is the activity of bringing together two or possibly more separate entities to conclude a deal between them concerning the sale and purchase of medicinal products without whoever is breaking the deal between these two or more entities actually owning at any one point the medicinal products involved in the deal. In Maltese this type of actor is known as the ‘sensar'.
Brokers are obliged to abide by the local regulations regulating their activity namely the relative articles in the Medicines Act (Chapter 458 of the Laws of Malta) and Subsidiary Legislation 458. 37 (Wholesale Distribution and Brokering of Medicinal Products and Active Substances Regulations).
The operations of brokers must also be in line with the relative parts of the European Union Good Distribution Practice (EU GDP) Guidelines published by The European Commission.
Inspections of brokering activities will be carried out against the national legislation as well as against the relative parts of the EU GDP Guidelines.
Good Distribution Practice Guidelines
S.L. 458.37 - Wholesale Distribution and Brokering of Medicinal Products and Active Substances Regulations.
Application for a wholesale dealer's licence for medicinal products for human use
Application for variation to a wholesale dealer's licence
Application for Registration for Brokerage Activity
Application for Registration for API Import & Distribution Activity
For the list of pharmacists accepted by the Medicines Authority to act as Responsible Persons in line with regulation 2 of Subsidiary Legislation 458.37 "Wholesale Distribution and Brokering of Medicinal Products and Active Substances Regulations", please click here
Further Information
For further information please send an email on inspectorate.adm@gov.mt