Throughout the European Union, high quality assurance standards are applied to the pharmaceutical and distribution industry so that the people buying and using these medicines can be sure of their quality, safety and efficiency. All pharmacy products manufactured and placed on the market in the European Union are evaluated by authorised institutions, and only those compliant with the strict requirements will be available for trade. Compliance with these requirements is guaranteed by certain certificates and licences. One of Norameda’s main goals is to ensure high-quality products, and all the available certificates and licences will guarantee this.
A manufacturing license is necessary for all manufacturers of medicinal products in the European Union, including those importing medicinal products from third countries. The production license entitles its holders to distribute medicinal products they produce or import in accordance with the requirements of good distribution practice.
WHOLESALE DISTRIBUTION LICENSE
The wholesale distribution license entitles a company to execute wholesale distribution activities in the declared territory and in accordance with the applicable pharmaceutical legislation. It is issued only after verifying that the distributor has adequate premises and equipment and complies with the requirements for the quality system, employees, document management, on-going operations, complaints, suspected counterfeits, refunds and cancellations, contractual activities, internal audits.
A CERTIFICATE OF GOOD DISTRIBUTION PRACTICE
A GDP ensures that the quality of medicines will be maintained at all stages of delivery, from production to points of sale. A GDP certificate is a document issued by the State Medicines Control Agency under the Ministry of the Republic of Lithuania certifying that the pharmaceutical activity carried out by the wholesale distribution license holder complies with the GPP requirements for medicinal products
A CERTIFICATE OF GOOD MANUFACTURING PRACTICE
A GMP ensures that the manufacture and import of medicines from third countries is controlled according to the applicable quality standards so that the manufactured medicinal product is fit for purpose, complies with the requirements of the marketing authorization and the specifications. A GMP certificate is a document issued by the State Medicines Control Agency under the Ministry of the Republic of Lithuania certifying that the pharmaceutical activity or any part thereof carried out by the manufacturing license holder complies with the GMP requirements.
AN APPROVAL CERTIFICATE OF FOOD BUSINESS OPERATOR
An approval certificate of food business operator is a document issued by the State Food and Veterinary Service whereby a business entity is entitled to carry out food handling activities, including distribution. The document is issued only if all the requirements of hygiene and other legislation applicable to this activity are met.