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Online Applications (E-Forms)

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  • Online Applications (E-Forms)

Please find the list of e-forms in online and PDF versions. Instructions on how to apply for each e-form can be found on the online application. 

Kindly fill in the Declaration form when signature/s is/are required.

The declaration form should be attached to the e-form and submitted online for each signatory.

 

126a new application/renewal: Online or PDF application

126a notification of variation:  Online or PDF application
Parallel import new application/ Parallel import renewal: Online or PDF application
Parallel import notification of variation: Online or PDF application
Request for sunset clause exemption: Online or PDF application
Article 61(3) notification: Online or PDF application
Batch specific request: Online or PDF application
Borderline classification request form: Online or PDF application
Withdrawal of MA/licence: Online or PDF application
Transfer of MA during procedure: Online or PDF application
Transfer of MA after MA is issued: Online or PDF application
Advertised Medicinal Product Complaint Form: Online or PDF application
Certificate of a Pharmaceutical Product Application: Online or PDF application
Certificate of GMP compliance of a manufacturer Application: Online or PDF application
Application for a Manufacturer’s / Importer’s Licence for Medicinal Products and / or Investigational Medicinal Products for use in Humans: Online or PDF application
Pharmacy Licence for Medicinal Products for Human Use Application: Online or PDF application
Qualified Person (QP) Status Application: Online or PDF application
Scientific Advice Request (SAR) or Protocol Assistance (PA): Online or PDF application
Variation to a manufacturer's, importer's or wholesale dealer's licence Application: Online or PDF application
Variation to a Pharmacy Licence Application: Online or PDF application
Wholesale Dealer's Licence for Medicinal Products for Human Use Application: Online or PDF application

Application for the importation and/or wholesale distribution of cannabis-based products or synthetic cannabinoid products in accordance with the Medicines Act and the Drug Dependence (Treatment not Imprisonment) Act: Online or PDF application

Application for a Licence in accordance with the Production of Cannabis for Medicinal and Research Purposes Act: Online or PDF application

Application for a Variation to a Licence issued in Accordance with the Production of Cannabis for Medicinal and Research Purposes Act: Online or PDF application

Medicinal Product Quality Defect Form: Online or PDF application

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Medicines Authority
Sir Temi Żammit Buildings,
Malta Life Sciences Park,
San Ġwann SĠN 3000
Malta

E-mail: info.medicinesauthority@gov.mt

Telephone: 356 2343 9000 (from 7:30 to 15:45)

Helpline: 356 2343 9111 (from 9:00 to 12:00)

Fax: 356 2343 9161

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