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Compliance and enforcement
What measures are in place to enforce the laws governing medicinal products?
The Medical Products Agency (MPA) is responsible for the regulation and surveillance of the development, manufacturing and sale of medicinal products. The MPA has certain enforcement powers and can, for example:
- order the recall of a medicinal product;
- perform audits of manufacturing facilitates and inspect procedures and documentation for good manufacturing practice requirements; and
- take action in cases of non-compliance and issue injunctions subject to penalty fines for non-compliance.
Decisions by the MPA can be appealed to the administrative court.
What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?
The Swedish Prosecution Authority investigates fraud and corruption crimes under the Swedish anti-bribery legislation. In addition to the Swedish anti-bribery, competition (antitrust) and fraud legislations, the rules of the Trade Association for the Research-Based Pharmaceutical Industry in Sweden provide the healthcare sector with ethical self-regulating rules and guidelines for avoiding dishonest practices.
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