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Declaración de conformidad CEMinisterio de Sanidad Política e IgualdadAgencia española de medicamentos y productos sanitariosGood Manufacturing PracticeUNE EN ISO

Products registered in the EU

500 Cosmetics products meet the general standards required of the major countries of the European Union and in the Spanish and European following records:

  • Ministry of Health Policy and Equality.Compliance with the provisions of Article 9 of Royal Decree 1487/2009 of September 26 on food supplements. According to Article 1 Subject matter and scope “regulates those foods which are concentrated sources of nutrients and presented for supplementing the intake of those nutrients from the normal diet.
  • Spanish agency for Medicines and Health.
  • GMP (Good Manufacturing Practice)Certificate of good manufacturing, are included within the concept of Quality Assurance, and are the factors that ensures that the products are manufactured in a uniform and controlled according to quality standards appropriate to their intended use and place the products according to the requirements for commercialization. GMP main aim is to reduce the risks inherent in any pharmaceutical production.
  • Operating License for health product installation.

Article 5.1 of Royal Decree 414/1996, of March 1, regulates healthcare products, proposed by the subdirectorate general of health care products having seen favorable report for health area of Madrid government delegation.

  • The Office of Harmonization for the Internal Market
  • Possession of Certificate of Registration for Community trade mark Gnetics Extender.
  • Declaration of Conformity
  • Certificate in which the EU manufacturer declares that the product meet the essential requirements of different directives application. This will allow the free movement of products within the European market. By adding the CE mark on these products, the manufacturer declares on his sole responsibility of the conformity of the product with all the legal requirements to ensure product validity.

The management system of 500 Cosmetics is based on a management system of quality:

  • UNE EN ISO 13485:2004 Health Products – Quality Management Systems – Requirements for regulatory purposes..
  • UNE EN ISO 9001:2000 Quality Management Systems. Requirements
  • UNE EN ISO 9004:2000 Quality Management Systems. Fundamentals and vocabulary
  • MDD 93/42/CEE Healthcare products Directive
  • Real Decreto 414/1996 Royal Decree Health Products
  • UNE EN ISO 14971:2007 Application of risk management to health products
  • UNE EN ISO 10993 Biocompatibility Test/li>

Other references that have been used in the conception of Quality Management Systems are:

  • ISO 14969 – ISO 13485 Guide
  • ISO 9001 for small business.
  • Geneva 2002
  • AEMPS Notice
  • MEDDEV Guides
  • MBMED Recommendations
  • ZLG, EK.MED Guides
  • EUCOMED Guides

The acceptance and commercialization of products made by mutual recognition and in accordance with the provisions of Articles 32 and 36 of the treaty of the operations of the European Union on the basis of administrative record only notified by the applicant.

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