Given the complexity of industry processes leading to development and manufacture of high quality therapeutic products, which are nevertheless subject to dynamic change with the evolution of science and technological possibilities, multiple Regulatory guidance documents are intended to harmonize the requirements on both the content and the presentation of data towards Competent Authorities.
All medicinal products – either pharmaceuticals, herbal medicines, or homeopathic products – need to be authorized before placing on market according to Directive 2001/83/EC as amended or Regulation 726/2004/EC as amended. Several other acts (e.g. Regulation 1901/2006, Directive 2001/20/EC) must be considered when preparing the Marketing Authorization Application.
Marketing Authorizations, once granted, need to be managed through variations, as per Regulation 1234/2008/EC, during their entire validity; and will be subject of at least one re-assessment within the frames of a renewal procedure after 5 years.
AccepTher has the know-how and resources either to act as a front-office towards Competent Authorities on behalf of its clients, or to provide consultancy by liaising with their own Regulatory staff, in order to facilitate the development, registration and up-to-date maintenance of their portfolio of pharmaceuticals.