Online Applications (E-Forms)

Please find the list of e-forms. 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.

After clicking the print button, save form to PDF and send via CESP. This applies to Licensing forms ONLY.


126a new application: Online or Direct Link application

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

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

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

Medicinal Product Quality Defect Form: Online or Direct Link application

Applying for Designation as a Notified Body under the  Medical Devices Regulation (MDR) /  In Vitro Diagnostic Devices Regulation (IVDR) 

 

 
For Medical Device application forms please click <here>