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Codes of statutes

The Medical Products Agency’s provisions and guidelines Following is a list of the provisions and guidelines issued by The Medical Products Agency that have been translated to English. Should you desire information concerning another provision or guideline we ask you to please contact us via phone or e-mail and we will do our best to assist you.

These consolidated texts are published for information purposes only. They generate no legal rights or duties; the instruments originally enacted, published and officially printed in Swedish are the only instruments that can do this, and they alone have the force of law. 

LVFS No.

Title

2005:11

The Medical Products Agency’s provisions on labelling and package leaflets for medicinal products;

2004:8

 

The Medical Products Agency’s Provisions and Guidelines for Marketing Authorization of Parallel Imported Medicinal Products (40 kb)

2003:6

 

The MPA's provisions and guidelines on clinical trials of medicinal products for human use

2003:2

 

Instructions regarding amendments to the Medical Products Agency’s provisions and guidelines (LVFS 1997:9) on the registration of certain homeopathic products;

2001:12

 

Medical Products Agency's provisions on the surveillance of medicinal products

2000:3

 

Examination of production batches of vaccines and blood products for human use prior to release on the Swedish market

1995:12

 

Payment of application and annual fees for medicinal products

1995:18

 

Authorization to place natural remedies on the market

1995:19

 

Authorization to place certain medicinal products for external use on the market

1996:17

 

Clinical trials of medicinal products

 

 

 

 

 
 

External links

 

Related information

Printed versions of the Codes of statutes can be ordered from:

Fritzes kundservice
SE–106 47 STOCKHOLM
SWEDEN

   
 
Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | phone: +46 18 174600, fax: +46 18 548566 | Contact information