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 They generate no legal rights or duties; the instruments originally enacted, published and officially printed in Swedish are the only instruments that can do this, and they alone have the force of law.
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LVFS No. |
Title |
| 2005:11 |
The Medical Products Agency’s provisions on labelling and package leaflets for medicinal products; |
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2004:8 |
The Medical Products Agency’s Provisions and Guidelines for Marketing Authorization of Parallel Imported Medicinal Products (40 kb) |
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2003:6 |
The MPA's provisions and guidelines on clinical trials of medicinal products for human use |
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2003:2 |
Instructions regarding amendments to the Medical Products Agency’s provisions and guidelines (LVFS 1997:9) on the registration of certain homeopathic products; |
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2001:12 |
Medical Products Agency's provisions on the surveillance of medicinal products |
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2000:3 |
Examination of production batches of vaccines and blood products for human use prior to release on the Swedish market |
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1995:12 |
Payment of application and annual fees for medicinal products |
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1995:18 |
Authorization to place natural remedies on the market |
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1995:19 |
Authorization to place certain medicinal products for external use on the market |
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1996:17 |
Clinical trials of medicinal products |