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Legal Basis
Readability testing on Package Leaflets for medicinal products is now a legal requirement as directed in EU legislation Article 59 (3) and 61 (1) of Directive 2001/83 as amended by Directive 2004/27/EC, which states that consultation with target groups is necessary to ensure that the package leaflet of a medicinal product is legible, clear and easy to use. Consultation with patient groups is now required for all applications for marketing authorisations.
The Organisation
Magmapharma is an organisation providing the services of highly qualified and professional regulatory consultants who specialise in providing comprehensive and detailed readability tests in consultation with target population groups throughout Europe. Magmapharma can also provide strategic advice and support to its clients throughout the testing process. Magmapharma has established a broad client base providing reports on a wide range of products which have been accepted throughout the EU authorities.
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| Please contact us for a competitive and professional quotation, we can assure you of a prompt and efficient service. |
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