EMA splitting of the Full Presentation Name of the medicinal …
The pharmaceutical form of a medicinal product should be described by a single full Standard Term of the European Pharmacopoeia using the plural form if appropriate (e.g. tablets) (see section 3).
Medicinal products in the European Union
A number of instruments have been put in place to guarantee that a medicinal product fulfils the legal requirements in terms of quality, safety and efficacy. These are the principles of good …
Introduction to the SmPC guideline
The SmPC guideline advises on the principles of presenting information in the SmPC to ensure the provision of clear information on the benefits and the risks of a medicinal product. It also …
Section 1: Name of medicinal product
Section 1: Name of medicinal product Strength of biological products should be expressed in terms of mass units, units of biological activity or international units as appropriate, reflecting …
ADV-G0003 Guide to definition of a human medicine v8
The definition of a medicinal product is given in Article 1 of Directive 2001/83/EC, by 2004/27/EC as described above. The definition is set out in two paragraphs, covering the presentation of …
Guide to Invented Names of Human Medicines
products in the centralised procedure or with the presentation of the name, strength and pharmaceutical form on the Summary of Product Characteristics (SmPC), label or package …
Guidance on the presentation of medicinal products
consumers of medicinal products are to a large extent laypersons who have the need for special protection against deception, misleading, overreaching and most of all they have the need for …
COMMENTS
The pharmaceutical form of a medicinal product should be described by a single full Standard Term of the European Pharmacopoeia using the plural form if appropriate (e.g. tablets) (see section 3).
A number of instruments have been put in place to guarantee that a medicinal product fulfils the legal requirements in terms of quality, safety and efficacy. These are the principles of good …
The SmPC guideline advises on the principles of presenting information in the SmPC to ensure the provision of clear information on the benefits and the risks of a medicinal product. It also …
Section 1: Name of medicinal product Strength of biological products should be expressed in terms of mass units, units of biological activity or international units as appropriate, reflecting …
The definition of a medicinal product is given in Article 1 of Directive 2001/83/EC, by 2004/27/EC as described above. The definition is set out in two paragraphs, covering the presentation of …
products in the centralised procedure or with the presentation of the name, strength and pharmaceutical form on the Summary of Product Characteristics (SmPC), label or package …
consumers of medicinal products are to a large extent laypersons who have the need for special protection against deception, misleading, overreaching and most of all they have the need for …