Directive 2010/84/EU on Pharmacovigilance and Directive 2011/62/EU, on the prevention of the entry into the legal supply chain of falsified medicinal products, has now been implemented into Spanish national law by the amendments to law 29/2006 on Guarantees and Rational use of Medicinal Products and Medical Devices.

In summary, the main amendments to the Law 29/2006 are the following:

  1.  New definitions
  • The definitions of active substance, excipient, medical device, personal care product and cosmetic product have been amended and further terms such as 'falsified medicinal product' have been included.
  1. Pharmacovigilance
  • Active substances: Distributors of active substances are required to comply with the good distribution practices of active substances. Pharmaceutical laboratories are required to use only raw materials manufactured according to good manufacturing practices for active substances and distributed according to good distribution practices. To ensure compliance, pharmaceutical laboratories will need to audit the manufacturing and distribution facilities of the manufacturers and distributors of active substances.
  • Excipients: Pharmaceutical laboratories must ensure that excipients are suitable for use in medicinal products by determining the appropriate good manufacturing practices and conducting formal risk assessments.
  1. Inscription in Registers
  • Manufacturers, importers or distributors of active substances must be registered with the  appropriate Registry to be created for this purpose by the Spanish Agency of Medicinal Products and Medical Devices (AEMPS), before the start of their activities.
  • The AEMPS shall furthermore set up a new Register for any person intermediating in the distribution of medicinal products for human use and established in Spain, to be registered before the start of their activities.
  1. Marketing Authorisation for medicinal products
  • The Law has been adapted to conform to the criteria used in the process for the authorisation, registration and conditions for the dispensation of industrially manufactured medicinal products for human use.
  • The Law allows the AEMPS to issue special authorisations for medicinal products that the Agency deems necessary to serve special requirements, as long as they are used on a specific patient under a prescription issued by a doctor and under his/her direct responsibility.
  • The cases for the withholding and the revocation of marketing authorisations are amended as follows: (i) both "efficacy" data and "safety" data will be included at the time of determining the risk-benefit ratio of a medicinal product which will allow the withholding or revocation of the marketing authorisation when such ratio is negative; and (ii) non compliance with the marketing authorisation conditions concerning pharmacovigilance will allow such withholding or revocation.
  • Lastly, the authority of AEMPS to modify the marketing authorisation for a medicinal product on the basis of public interest or public health or safety protection, is understood without prejudice to the obligation of the marketing authorisation holder to ensure that the product information is up to date with the latest scientific knowledge, including the conclusions of the evaluations and recommendations published in the European medicinal products and the AEMPS websites.
  1. Branding of medicinal products
  • Brands may be used for generics to the extent the brand would not be confused with a Spanish official name or with an International Non-proprietary Name (INN) or be misleading about the therapeutic properties or the nature of the medicinal product. These same requirements apply to manufacturers of innovative medicinal products.
  • The Acronym GPE (Generic Pharmaceutical Equivalent) (EFG - Equivalente Farmacéutico Genérico) is reserved for those medicinal products determined by the AEMPS due to their interchangeability.
  1. Prescriptions and substitution
  • Physiotherapists are given the authority to indicate, use and authorise the dispensation of over-the-counter medicinal products (not subject to medical prescription) and medical devices related to the practice of their professional activity, through a dispensation order.
  • The relevant Autonomous Regions bodies are required to provide a prescription assistance system to those in charge of prescriptions.
  • Pharmacists are no longer required to dispense a biosimilar medicinal product when a  prescription is issued under a commercial name, if the price of the prescribed medicinal product and the price of the biosimilar medicinal product was the same and there was no cheaper medicinal product in the same group. In this case, the regulation currently in force concerning substitution and interchangeability shall apply.
  1. Advertising
  •  Advertising of non-prescription medicinal products does not require prior administrative approval. Nevertheless, the relevant health authorities shall carry out checks to ensure that the advertising contents comply with applicable laws and regulations and faithfully reflect the scientific and technical conditions contained in the marketing authorisation.
  • With regard to the advertising of medical devices, the Law states that (i) medical devices intended to be exclusively used and applied by health professionals cannot be advertised to the general public; and that (ii) the advertising of medical or surgical techniques or procedures associated with the use of specific medical devices must comply with the criteria indicated in the advertising of medical devices.
  1. New interim/preventive measures
  • The Law establishes the following new interim/preventive measures: (i) the suspension of the manufacturing, prescription, dispensation and supply of investigational medical devices, and (ii) the limitation, prohibition, suspension or the subjecting to special conditions of the manufacturing, importation, marketing, exportation, advertising, commissioning and use of medical devices, cosmetics and personal hygiene products as well as the placing under quarantine, marketing withdrawal and recovery of such products.      
  1. Infringements concerning medical devices, cosmetic products and personal care products
  • The Law creates a specific catalogue of infractions of medical devices, cosmetics and personal care products.
  • In addition to the infractions already established in the previous version of the Law, the Law establishes the following specific infractions relating to medical devices:
  • minor infractions: (i) to present at trade fairs, exhibitions and demonstrations products which are unfit to enter the market or be commissioned, without alerting the authorities of their unfit condition or inability for service; (ii) not making available to the patient the appropriate declaration for customised products; not informing the patient about the latter or not providing such declaration at the patient's request; or (iii) not identifying as export products, products which are exclusively destined for export;
  • serious infractions: (i) not providing the patient with or not including in his clinical history all the mandatory information about the product he has received or the implantation card, when so required, as well as omitting to send such card to the supplier or to the national register established for such purpose; or (ii) distributing implantable products without providing the appropriate implantation card when mandatory, as well as the improper handling of such cards; and
  • very serious infractions: (i) selling devices for genetic diagnostic to the public; or (ii) having a professional handle products under conditions and for purposes other than those indicated by the manufacturer, or by unqualified personnel or by personnel who is not duly trained, putting at risk human health and safety.
  1. Application of the Law to medical devices, cosmetic products and personal care products
  • The Law expressly establishes that the conditions and requirements for the manufacturing, importation, clinical trials, distribution, marketing, commissioning, dispensing and use of medical devices (and cosmetic products and personal care products, when applicable) as well as their respective administrative procedures, will be established by further regulation within the framework established by the European Union.
  • The Law, furthermore, states that the manufacturing and importation of cosmetic products and personal care products will be subject to the responsible declaration regime established in Law 30/1992, of 26 December, governing the Public Administration Legal Regime and the Common Administrative Procedure. Such responsible declaration shall be filed with the AEMPS. The submission of the filing will allow the commencement of the activities, subject to subsequent verification by the AEMPS, through documentary verification, and where applicable, the inspection of the elements and circumstances declared in the responsible declaration.