Manufacturing of medicinal products

The manufacturing of medicinal products includes manufacturing, packaging or repackaging.

The manufacturer of finished medicinal products or intermediate products (sometimes referred to as bulk or semi-finished products) must have an authorisation for such manufacturing. The same applies to importers of medicinal products or intermediate products from countries outside of the European Economic Area (EEA).

Operators which manufacture active substances, or carry out quality control on medicinal products, do not need authorisation, but must still comply with GMP.

Qualified Persons

All manufacturers of medicinal products must have at least one Qualified Person. The Qualified Person does not have to be an employee and can be hired as a consultant. In order to be a Qualified Person, it is necessary to have sufficient training and experience.

Being a Qualified Person implies a major responsibility, as this person guarantees that the quality of batches of medicinal products that are being certified both comply with GMP and fulfil the requirements of the marketing authorisation for the medicinal product concerned.

Inspection

Prior to issuing a manufacturing authorisation for a new operation, the Swedish MPA will carry out an inspection of the company site, covering for instance equipment, premises and quality systems. Inspections will subsequently be conducted on a regular basis.