Summary of product characteristics guideline








Product information Reference documents and guidelines

12/27/2014
09:19 | Author: Steven Lewis

Summary of product characteristics guideline
Product information Reference documents and guidelines

Guideline on the summary of product characteristics for anthelmintics, (English only), adopted, , . Concept paper on the need to elaborate.

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This page lists the reference documents and guidelines on the quality of product information for centrally authorised veterinary medicines, including style, terminology, use of abbreviations and the translations of standard terms into European Union (EU) languages. Back to top Back to top Back to top EMA.

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Product information I - World Health Organization

10/26/2014
07:22 | Author: Chloe Allen

Ativan side effects
Product information I - World Health Organization

Guidance note to Applicants (Manufacturers) on the compilation of the WHO Public Summary of Product Characteristics (SPC or SmPC): Main scientific.

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Summary of Product Characteristics templates and fragments MHRA

8/25/2014
05:17 | Author: Molly Young

Summary of product characteristics guideline
Summary of Product Characteristics templates and fragments MHRA

This page contains Summary of Product Characteristics (SmPC) templates SmPC section 1 - Product name Word file (opens in new window).

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This page contains Summary of Product Characteristics (SmPC) templates and fragments.

Home How we regulate Medicines Licensing of medicines Information for licence holders Licence authorisation application forms and registration forms Summary of Product Characteristics templates and fragments.

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