Our Commitment
For Pharm RE Limited, licensing is more than a formal requirement. It reflects our commitment to professionalism, transparency, and compliance in the conduct of our activities.
We are dedicated to carrying out our broker and wholesale distribution activities in a responsible, reliable, and compliant manner, with due regard to applicable regulatory standards.
Our Regulatory Status
Pharm RE Limited is registered with the Malta Medicines Authority as a Broker of Medicinal Products for Human Use under registration number BR07, as a Wholesale Dealer’s Licence under authorisation number WL158 (1st Variation) and also holds a Certificate of GDP Compliance of a Wholesale Distributor in relation to its licensed wholesale distribution activities.
Key Regulatory Information
– Registered Broker:
BR07
– Wholesale Dealer’s Licence:
WL158 (1st Variation)
– GDP Certificate:
MT/004HW/2026
– Licensed site and registered office:
50A Triq l-Irmiġġ, L-Imsida MSD 1012, Malta
Licensing
At Pharm RE Limited, licensing and regulatory compliance are integral to the way we conduct our activities. The company operates within Malta’s regulated pharmaceutical framework and is supervised by the Malta Medicines Authority. Malta Medicines Authority states that licences for pharmaceutical activities are issued upon establishing that the relevant GxP requirements and provisions of the Medicines Act are achieved, and that such licences may be revoked, suspended, or varied if the applicable standards are not maintained.
Our regulatory status reflects the scope of our activities in the field of medicinal products for human use and our commitment to conducting these activities in a professional and compliant manner.
Regulatory Framework
The regulatory framework applicable to our activities is based on Maltese legislation and European pharmaceutical rules governing medicinal products for human use. Malta Medicines Authority explains that a wholesale dealer’s licence is required in order to trade in medicinal products, and that wholesale dealers are required to source medicinal products from licensed entities and sell or distribute only to other licensed wholesale dealers and pharmacies.
The Authority further explains that brokers are subject to the applicable provisions of the Medicines Act, Subsidiary Legislation 458.37, and the relevant parts of the EU Good Distribution Practice Guidelines.
GDP Compliance
Pharm RE Limited also holds a Certificate of GDP Compliance of a Wholesale Distributor, certificate number MT/004HW/2026, issued on 13 February 2026.
As reflected in the attached certificate, the GDP certificate was issued following a variation application to change the licensed site and a subsequent limited-scope variation inspection carried out on 12 January 2026. The certificate confirms compliance of the wholesale distributor with Good Distribution Practice (GDP) requirements.
Malta Medicines Authority states that wholesale distributors of medicinal products for human use are regulated in line with EU GDP guidelines, and that inspections are carried out to ensure compliance with legislation and GDP requirements. The Authority also states that inspections are held at licensed sites and that proposed sites for new licences are also inspected.
Pharm RE Limited, 50A Triq l-Irmiġġ, L-Imsida MSD 1012, Malta, Company Registration Number: C 10374 (Malta Business Registry)
Company is regulated by Malta Medicines Authority, Licensed Wholesaler WL 158, Registered Broker BR07
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