The Pharmaceutical Law Department at EJASO ETL GLOBAL provides expert advice and legal assistance to companies in the health and pharmaceutical sectors.

Pharmaceutical, healthcare and biotechnology sectors are regulated industries, subject to European, State and regional laws, requiring a thorough knowledge of the applicable legislation and experience in its implementation in the wholesale pharmaceutical association (PHARMACEUTICAL INDUSTRY).

EJASO ETL GLOBAL has a broad overview of the sector, and our experts are able to give comprehensive advice in a range of areas:

Regulatory

  • Authorisation, sale, registration and price procedures vis-a-vis medications and medical devices.
  • Regulatory compliance of special medications (vaccinations, medications of human origin, advanced therapies, radiotherapy medications, medicinal plants, medicinal gases, etc)
  • Special medical authorisation procedures (compliance with generic medication requirements, advanced therapy, orphan drugs).
  • Problems with drug supplies and parallel trade.
  • Public liability for defective drugs.
  • Use of non-authorised drugs or in special situations (compassionate use, off-label use)
  • Advice on innovation and development of drugs: pharmaceutical patents.
  • Compliance with quality standards, specifications and information about medications: manufacturing and labelling.
  • Laws governing pharmaceutical manufacturers (manufacturer, importer, third party manufacturers, title hold of marketing authorisation).
  • Advice on compliance manufacturing master formulas and official products.
  • Advice on healthcare products: sanitary products, cosmetics and products and personal care, biocides, food supplements and functional foods.
  • Public finance and drug price fixing.
  • National Health Service price transparency.
  • Advice on penalties system and responsibility for drug-related activities.

Pharmacovigilance.

  • Drug traceability.
  • Cost-benefit ratio of medications: Executive instrument.
  • Assessment and communication of information.
  • Inspections and control of risks relating to medicinal products.
  • Modification, suspension and revocation of marketing authorisation.
  • Quality control.
  • Observational-type marketing control of medicinal products: post-authorisation studies of medicinal products.

Advertising of medicinal products

  • Advertising in the pharmaceutical sector, applicable regulations and self-regulation systems.
  • Advertising of prescription drugs, over-the-counter medicinal products and medical devices.
  • Advice on transparency in transfers of values to professionals and health organisations.
  • Advice on advertising and information aimed at qualified health professionals to prescribe or dispense medications.

Pharmaceutical industry

  • Advice on compliance with the legal and ethical regulations on medications and health products.
  • Compliance with the Pharmaceutical Industry’s Code of Good Practices.
  • Internal procedures and protocols that facilitate compliance with obligations in the advertising area.
  • Service agreements with healthcare professionals in accordance with the provisions established by the Spanish Code of Good Practices for the Promotion of Medicines and Interaction with Healthcare Professionals and the Code of Good Practices of the Pharmaceutical Industry.

Specialist subjects

  • Legal advice to pharmaceutical manufacturers.
  • Legal advice to distributors of medications and medical devices.
  • Legal advice in investigations and galenic formulation of medicinal products.