National Pharmacopoeia Authority

In Sweden, the Swedish Medical Products Agency (Swedish MPA) is appointed to be this national contact authority. One task of this authority is to appoint experts at the European level as well as members of the Swedish committee.

The responsibility for the Council of Europe in Sweden lies with the Ministry of Foreign Affairs. The Ministry of Foreign Affairs has handed over responsibility for the European Pharmacopoeia to the Ministry of Social Affairs, which in turn has delegated to the Swedish MPA to function as the national pharmacopoeia authority.

The Swedish MPA appoints a Swedish delegation to represent the Swedish Pharmacopoeia Authority in the European Pharmacopoeia's commission meetings.
 
The national pharmacopoeia authority is the link between EDQM, the Swedish MPA and the users of the European Pharmacopoeia.

The Swedish pharmacopoeia authority is located at the Swedish MPA. There is also an external advisory group, the Swedish Pharmacopoeia Committee (SFK).

Task of the Pharmacopoeia Authority

• Responsibility for ensuring that the European Pharmacopoeia becomes a valid standard in Sweden. This is done by establishing regulations after each new edition and supplement of the European Pharmacopoeia.
• Responsibility for issuing the Swedish Medicines Standard (SLS).
• Proposes experts to the European Pharmacopoeia's expert and working groups.
• Proposes the Swedish delegates to the European Pharmacopoeia Commission.
• Proposes members to the Swedish Pharmacopoeia Committee.
• Conveys Sweden's and Swedish users' wishes and their needs for what the European Pharmacopoeia should contain.

The Swedish Pharmacopoeia Committee

The Swedish Pharmacopoeia Committee (SFK) is an advisory committee that helps the Swedish Pharmacopoeia Authority to review texts published in Pharmeuropa and to produce views and comments on the texts which are then submitted to EDQM.

SFK has three subgroups:

• galenic
• biology/biotechnology
• chemistry.

The members are experts in their field and come from authorities, industry, academia and Swedish healthcare. Many of the members are also experts in the European Pharmacopoeia's expert and working groups.