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Advertising medicinal products.

We advise clients on all compliance matters relating to European medicines advertising regulations, HCP and HCA agreements, patient advocacy, and pharmaceutical industry support to scientific research, innovation and healthcare. 

EU advertising legislation

Advertising regulations aim to ensure a high level of public health protection, and the quality, safety, and efficacy of medicinal products. In Europe, the advertising of medicinal products is subject to strict regulations.  The advertising of prescription-only medicines to the general public is prohibited. The advertising of non-prescription medicines (over-the-counter or OTC medicines) is allowed subject to specific requirements and avoidance of disguised promotion.   Advertising must be compatible with the information in the summary of product characteristics (SPCs).  Inducements to prescribe or supply medicinal products, such as gifts or pecuniary advantages are prohibited, and the supply of free samples is subject to restrictions. 

 

Malta advertising regulations

The advertising of medicinal products for human use in Malta is governed by the Medicinal Products (Advertising) Regulations (SL 458.32), which transpose European Directive 2004/27 into Maltese law and regulate advertising to the general public and to healthcare professionals (HCPs) and healthcare associations (HCAs). The Malta Medicines Authority does not review advertising prior to its publication, and monitors advertisements and investigates complaints.  

It is unlawful to advertise medicinal products that have not been granted marketing authorisation. No medicinal  products  may  be  distributed  directly  to  the public by the pharmaceutical industry for promotional purposes. There are exceptions to the advertising requirements with respect to vaccination campaigns carried out by the pharmaceutical industry that are granted approval by the Licensing Authority. 

 Qualified entities such as consumer associations may issue compliance orders, administrative penalties, and other administrative sanction under the Medicines Products (Injunction to Advertising) Regulations (SL 458.51), which transpose European Directive 92/28.

 

Advertising to healthcare professionals (HCPs). 

According to the Medicines Act, advertising of medicinal products for human use includes sponsorship of scientific conferences, events, and hospitality for licensed Maltese health care professionals (HCPs) and provision of samples of medicinal products to HCPs.  Advertising to professionals qualified to prescribe or supply medicinal products must be truthful, accurate, and compliant with the approved summary of product characteristics (SPCs).   

Medical professionals’ endorsement of and association with commercial products and services, including nursing homes and private clinics, in Malta is strictly regulated by law.   Medical practitioners are not permitted to participate in any division or sharing of fees which the patient or the client are not aware of. 

Medical practitioners are not allowed to pay any commission or allow any discount or any other arrangement with each other or with any proprietor of a business concern. A  medical practitioner   may   not   accept   payment of a   commission   for   the introduction of a patient or a client to a consultant, private hospital or other institution, medical practitioner, dental surgeon or dentist, veterinary surgeon, pharmacist, nurse, midwife or any other person or company.

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