Identification and classification of pharmaceutical products
This service allows product owners to obtain official guidance from the NHRA on the regulatory classification of their pharmaceutical, health, or nutritional supplement products. Applicants must submit the product composition certificate, a sample, and all labeling documentation. NHRA classification determines whether the product falls under regulatory control and assigns the appropriate category, with an official classification letter issued. Products subject to NHRA oversight must be registered to ensure quality, safety, and efficacy. Classification by NHRA does not constitute product registration, and a separate registration application must be submitted in accordance with applicable regulations.
Required Attachments
- Classification Checklist , View Document
- Commercial Registration certificate
- Internal and external label
- Sales licence certificate
- A sample
- Letter of request
- Application form , View Document
- Compsition of the product
- Medicine Information leaflet
- Payment receipt
- Certificate of product composition from the manufacturer
- Certificate of registration from the country of origin
Legal Regulations
- Decree-Law No. (18) of 1997 regulating the pharmacy profession and pharmaceutical centres
- Decree-Law No. (2) of 1987 regarding the practice of paramedical professions by non-doctors and pharmacists
- Decree-Law No. (7) of 1989 regarding the practice of human medicine and dentistry
- Decree-Law No. (20) of 2015 amending some provisions of Decree-Law No. (18) of 1997
Fees
- 20 BD : Pharmaceutical Product Classification fees
Process Time
- 30 Working Days
Service Provider
National Health Regulatory Authority
Cooperative Entities
- Ministry of Health