Safety Recalls

In order to protect public health, it may become necessary to recall stock of medicinal products for human use due to pharmacovigilance/safety issues. Recalls due to combined safety and quality issues are also possible.

The recall of stock from the marketplace can apply to all authorised medicinal products (i.e. all marketing authorisations, authorisations in line with 126a, centrally authorised products, parallel imports, unlicensed medicinal products (article 20) and medicines which are available in Malta through a named patient basis or compassionate use programmes).

Once a recall is confirmed, the Post Licensing Directorate at the Medicines Authority is responsible for co-ordinating all aspects of pharmacovigilance/safety related recalls in Malta.

The basis for the recall of stock due to safety or pharmacovigilance reasons can be due to a Community Decision (as published in the Official Journal of the European Union), or a decision taken by a marketing authorisation holder to withdraw a marketing authorisation.

For Marketing Authorisation Holder

When a recall is confirmed, Marketing Authorisation Holders should inform the Medicines Authority about its co-ordinated plan to carry out the recall. The submission package could contain as applicable:

1. Direct Healthcare Professional Communication (DHPC) and Action Plan
2. Details about stopping the supply to wholesale dealers or pharmacies and the date of implementation
3. Dissemination letters both to Pharmacies and wholesale dealers

The submission package can be sent electronically to postlicensing.medicinesauthority@gov.mt. The Medicines Authority will then review and approve the materials and upload any DHPC/Safety Circulars/Letters as applicable.

After the recall has been carried out a Reconciliation Report should be sent to the Inspectorate and Enforcement Directorate at Medicines Authority.

Enquiries and Further Information

For further information consult the Guidance Notes for Pharmaceutical Companies on Pharmacovigilance Obligations & Adverse Drug Reaction (ADR) Reporting Requirements for Medicinal Products for Human Use.

Enquiries can be made by mail, email, fax or telephone:

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