Service Directory
Health Product Variation
This service allows holders of NHRA-approved health product licenses to request updates to their product information when any changes occur during the product’s lifecycle. These changes may include updates to the Marketing Authorization Holder (MAH), manufacturing site, packaging, shelf life, or storage conditions. Changes to the active ingredient (API) or adding a new pack size are not covered by this service. In such cases, a new product registration application must be submitted.
Service Conditions
- a complete application should be submitted with all the required documents.
- change to the active pharmaceutical ingredient (API) and addition of pack size of the product will not be considered a variation. In such cases, the applicant is required to submit a new registration application.
Required Attachments
- Health Product Licensing Guidelines_V 2.0 , View Document
Legal Regulations
- Law No. (63) of 2019 on issuing requirements and procedures for the practice of the pharmaceutical profession and the licensing of pharmaceutical centers, factories and facilities.
- Law No. (12) of 2015 concerning the regulation of the drug registration system.
- Decree-Law No. (18) of 1997 regulating the profession of pharmacy and pharmaceutical centres
Process Time
- 30 Working Days : for the online requests
Service Provider
National Health Regulatory Authority
Cooperative Entities
- Ministry of Health
