Regulatory Overview
This section explains the process for approval of manufacturers who would be eligible to apply for registration of their products in Sri Lanka.
Information is also given to provide guidance on the type of applications and how to apply for the approval of relevant manufacturing facilities.
Approval of Foreign Manufacturing Facilities
Introduction & Scope:
The process applies for overseas manufacturing sites who intended to get marketing authorization for their products in Sri Lanka. The procedure includes a desk review of essential documents including the site master file. A GMP inspection of the site may be necessary before approval of the site.
A foreign manufacturer who wants to register products in Sri Lanka needs to appoint a Sri Lankan business entity as its local authorized agent. The local agent will furnish applications on behalf of its principal company, the foreign manufacturer. A separate application needs to be submitted to each manufacturing site from which the manufacturer plans to export products to Sri Lanka.
Application has to be submitted online via NMRA’s web portal eNMRA which requires uploading of essential information and documents to enable a desk review. If all documents indicate fulfilment of NMRA requirements, the next step would be to carry out a GMP inspection of the facility. The NMRA Act, No. 5 of 2015 (section 51) & regulations 2 to 10 of part I of medicines regulations pronounce the legal requirements. The NMRA would exempt onsite GMP inspection if the particular site had been inspected by a stringent NRA or WHO, in terms of regulation 24 of the medicines regulations. After these procedures, an approved foreign manufacturer can submit an application for marketing authorization of its products through the local agent.
Flow Chart- Foreign Manufacturing Site Approval
Licensing of Local Manufacturing facilities
The process applies for local manufacturing sites who intended to get marketing authorization for their products in Sri Lanka. The procedure includes a desk review of essential documents including the site master file and several GMP Inspections.
A local manufacturer who wants to register products in Sri Lanka needs to furnish applications regarding his manufacturing facilities. A separate application needs to be submitted to each manufacturing site.
Application has to be submitted online via NMRA’s web portal eNMRA which requires uploading of essential information and documents to enable a desk review and GMP Inspections.
The NMRA Act, No. 5 of 2015 (section 51) & regulations 26 to 30 of part II of medicines regulations pronounce the legal requirements.
After these procedures, an approved Local manufacturer can submit application for formulation approvals.
After obtaining the formulation approval and GMP approval for commercial manufacturing of the facility, local manufacturer can apply for the product registration. After that, local manufacturer can apply for the manufacturing license.
Stages for beginners;
- Local manufacturer’s profile creation
- Approval of the proposed layout of the manufacturing plant
- Initial land inspection (optional)
- Approval for the formulations
- Initial building inspection -during the construction (Optional)
- Inspection of the plant before installing the manufacturing equipment and machineries after completion of construction of the building
- Application to request inspection of the plant after completion of the installment of manufacturing equipment and machineries including necessary qualifications (Complete SMF)
- Approval of the manufacturing facility (Licensing of manufacturing site)
- Inspection of the plant to get approval for commercial batch manufacturing (GMP Inspection)
- Application for GMP certificate (Optional)
- Application for product registration
- Application to get manufacturing licenses for individual products
- Application to get COPP/FSC (Optional)
Site Master Files
Site Master Files are submissions to NMRA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of Medicines, Medical Devices, Borderline products and cosmetics.
Guidance for Site master Files
Guidance for Site master Files
Site Master file of Medicines (Click Here)
Site Master file of Medical Devices (Click Here)
Site Master file of Borderline Products
Site Master file of Cosmetics (Click Here)
References:
- WHO guideline for drafting a site master file, Annex 14, WHO TRS No. 961, 2011
- Explanatory notes for pharmaceutical manufacturers on the preparation of a site master file; PE 008 – 4, 1 January 2011, Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Good Manufacturing Practices (GMP)
Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
The National Medicines Regulatory Authority Act No. 5 of 2015 interprets GMP guidelines as ‘good manufacturing guidelines issued by the World Health Organization’. As such, the National Medicines Regulatory Authority (NMRA) adopts the WHO GMP guidelines along with its subsequent updates for the purpose of regulation of pharmaceutical manufacture. The manufacturers are expected to adhere to the Good Manufacturing Practices throughout their activities.
Pharmaceutical manufacturers who intend to apply for marketing authorization in Sri Lanka may be subjected to one or several GMP inspections prior to their site approvals.
GMP Guidelines available on WHO website:
WHO good manufacturing practices for pharmaceutical products: main principles:
https://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS986annex2.pdf?ua=1
WHO good manufacturing practices for sterile pharmaceutical products:
WHO good manufacturing practices for biological products:
https://www.who.int/publications/m/item/annex-2-WHO-gmp-for-biological-products
Guidelines
Guideline on Approval of an Overseas Manufacturing Plant of Medicines
Guideline on Preparation of Site Master Files
Guideline for preparation and conduct of the GMP inspection