EU-GMP COMPLIANCE CERTIFICATE
HOW & WHY TO GET EU-GMP COMPLIANCE CERTIFICATE FOR CANNABIS INDUSTRY
Written By :
Mussarat Fatima
INTRODUCTION
It has been seen over the years of cannabis legalization in Canada that Canadian cannabis licensed producers (LPs) are involved in obtaining EU-GMP certification for their facilities. Compliance with EU-GMP results in high-quality products for distribution in the Canadian market, as well as the opening of the market for medical exports to European nations.
As more LPs express interest in getting their facilities certified for EU-GMP compliance, we will first explore what EU-GMP is and why we need it, what is good agricultural and collection practices (GACP), as well as who and why we need Good Distribution Practices (GDP), according to European Medicine Agency (EMA).
The EMA requires herbal products derived from plant material to adhere to GACP. Establishing a GACP for herbal starting materials is critical in order to ensure the acceptable and consistent quality of medicinal plant/herbal compounds. The quality of herbal starting ingredients demands a proper quality assurance technique, including material gathering and/or cultivation, harvesting, and primary processing.
In order to receive EU-GMP Compliance certification for exporting cannabis for medical purposes to the European market, the LP must demonstrate GACP compliance.
GOOD MANUFACTURING PRACTICE (GMP)
Good Manufacturing Practice (GMP) is a concept that applies to the manufacture, processing, and distribution of goods.
The term “good manufacturing practice” (GMP) refers to the minimum level that a pharmaceutical producer must adhere to in their manufacturing procedures. The European Medicines Agency (EMA) conducts inspections to ensure compliance with these standards and plays an important role in harmonizing GMP activities across the European Union (EU).
Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with GMP.
GMP requires that medicines:
- are of consistently high quality
- are appropriate for their intended use
- meet the requirements of the marketing authorization or clinical trial authorization.
EU-GMP COMPLIANCE CERTIFICATE
GOOD DISTRIBUTION PRACTICE (GDP)
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain.
Compliance with GDP ensures that:
- medicines in the supply chain are authorized in accordance with European Union (EU) legislation
- medicines are stored in the right conditions at all times, including during transportation
- contamination by or of other products is avoided
- an adequate turnover of stored medicines takes place
- the right products reach the right addressee within a satisfactory time period
- The distributor should also put in place a tracing system to enable finding faulty products and an effective recall procedure.
GDP also applies to the sourcing, storage, and transportation of active pharmaceutical ingredients and other ingredients used in the production of the medicines.
Anyone engaged in the activity of wholesale distribution of medicinal products in the European Economic Area (EEA) must hold a wholesale distribution authorization issued by the national competent authority of the Member State where they carry out these activities. The same national authority is responsible for inspecting the wholesale distributor.
OTHER REGULATORY REQUIREMENTS
In addition to compliance with the European requirements, if an LP is interested in exporting medical cannabis to Europe, they will also need to comply with all Health Canada’s applicable regulations. Some examples may be applying for an import/export permit and compliance with Canadian Food Inspection Agency (CFIA) relevant guidelines.
MUSSARAT FATIMA
Mussarat Fatima, President, and owner of MF Cannabis License and Regulatory Consultants has more than twenty years of experience in Quality Assurance, Quality Control, and Regulatory Affairs within the pharmaceutical, Food and Cannabis industries. She has a Master’s Degree in Food Sciences and Biochemistry; in addition to this, she also has a diploma in pharmaceutical Quality Assurance, Regulatory Affairs, and Quality Control. Also, she has completed several certifications specifically in Cannabis Quality Assurance, Regulatory Affairs, and Facility management from recognized institutes in Canada.
Written By: Mussarat Fatima
President at MF License & Regulatory Consultants
Website: https://mflrc.com/
Contact: info@mflrc.com