The pharmaceutical sector, as regulated environment is characterized by its specificity and detail. The long history of Tornos Abogados in the area of administrative law together with its knowledge of this area allows us to advise pharmaceutical companies, as well as health hospital foundations or organizations in their own business core on legal issues.
Authorization procedures and drug registration and reporting and classification of medical products.
• Labeling and packaging of medications and medical products.
• Price system and procedure for inclusion in the pharmaceutical services of the National Health System.
• Procurement procedures and modification of authorizations for pharmaceutical laboratories.
• Compliance with pharmacovigilance obligations.
• Assistance in proceedings before public entities related to drugs and medical products, both in the administrative phase as in the contentious phase.
Advertising and compliance
• Review of promotional materials to ensure compliance with legal and ethical rules of advertising for medicines and health products.
Review and adaptation of web sites and digital platforms targeting both health professionals and the public in general.
Development of normalized procedures and protocols for compliance with the guidelines established by the Code of Practice of Pharmaceutical Industry.
• Assistance and advice in proceedings before Pharmaindustry , FENIN and Self-control.
• Contracts for research (clinical trials, observational studies, biomedical research).
• License Agreements.
• Supply and distribution contracts.
• Contracts for the manufacturing of drugs and active ingredients.
• Joint venture contracts.
• Contracts for treatments of specially protected data (treatment of genetic data and biological samples, access and transfer of data concerning health).
*Access protocols, custody and preservation of clinical documentation.
• Liability for healthcare.
• Compliance with the rules of data protection and patient autonomy in the framework of clinical studies.
• Legal advice on the procedures for implementation of ICT in health care activity (digital medical records, electronic prescriptions, telemedicine and tele-assistance).
• Preparation and review of informed consent documents from the regulatory framework to protect personal data, patient autonomy and biomedical research.
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