Fields of law
We offer companies in the pharmaceutical and food industries, as well as individuals and organizations working in healthcare, quick and straightforward practical solutions at competitive prices.
Information about our specialties
-
Admissions
Regulatory issues relating to marketing authorisation, exemptions and special procedures (formula drugs, fast-track procedures, Article 13 TPA)
Orphan Drugs
Orphan drugs und compassionate use, requirements, and admissibility
Off-label use
Limits and possibilities
Pharmacovigilance, market surveillance
Technical responsibility and reporting obligations
Distribution and dispensing
Dispensing categories, mail order, self-dispensing
Advertising and communication
Advertising to healthcare professionals and the general public, promotion and information, internet presence
Financial benefits
Discounts, retrocessions, Pharma Cooperation Code, donations, events sponsorship, service contracts
Parallel imports
Requirements for parallel imports
data / market protection
Duration of protection, generics.
Delimitations
Distinctions from medical devices, food supplements, cosmetics
-
Ethics Committees, FOPH, Swissmedic
Research with medicinal products for human use, licensing requirements, cooperation with ethics committees, FOPH and Swissmedic
Good Clinical Practice (GCP)
Division of responsibilities between investigator and sponsor; investigator-initiated studies
Non Interventional Studies
Non‑interventional studies, practice experience reports and observational studies
-
Manufacturing, wholesale, retail, GMP, GDP
Outpatient medical institutions, self-dispensation
-
Campaigns for professional and public advertising
Advice and legal assessment, including cooperation with advertising agencies
Internet
Websites, apps, social media
Pecuniary benefits, gifts, and discounts
Support for health care organisations (HCO) and health care professionals (HCP), discounts on therapeutic products, sponsoring and donations, gifts
Pharma Code and Pharma Cooperation Code
Scope of application and content, relationship with the Therapeutic Products Act, transparency obligations, prohibition of gifts
Samples
Samples for healthcare professionals and samples for the general public, use of samples for promotional purposes
-
Definition and delimitation
Definition, delimitation with respect to therapeutic products, food supplements, and cosmetics
New and global approach and marketing
Requirements, technical documentation, conformity
Conformity assessment and notification obligations
Technical documentation, conformity assessment bodies, technical standards, CE marking
Market surveillance
Materiovigilance, post‑market surveillance system and advertising
-
General reimbursement issues relating to the Specialities List (SL), the list of specialty drugs for birth defects (GGML) and the list of therapeutic products and medical devices (MiGeL)
Reimbursement of medicinal products outside the approved indication/limitation (off‑label / off‑limitation use) or outside the SL (hors-liste)
Review of authorisation conditions (price review)
-
Professional licence requirements
Rights and obligations regarding medicinal products (use, dispensing and self‑dispensing)
Regulatory aspects concerning permissible activities, scope of practice
-
Requirements for the collection of medical data
Transfer of medical data / personal data abroad (e.g. in the context of clinical trials)
Communication of data to foreign authorities
Technical and organisational data protection measures
Right to information and inspection
-
Delimitations
Delimitation in respect of medicinal products and medical devices
Marketing of food supplements
Claims and health claims
Cosmetics
Links to legal foundations
Therapeutic products law
TPA, Federal Act on Medicinal Products and Medical Devices
MPLO, Ordinance on Licensing in the Medicinal Products Sector
VAM, Ordinance on Medicinal Products
AMZV, Ordinance of the Swiss Agency for Therapeutic Products on the Requirements for the Authorization of Medicinal Products
VAZV, Ordinance of the Swiss Agency for Therapeutic Products on the simplified authorisation of medicinal products and the authorisation of medicinal products under the notification procedure
KPAV, Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Authorization and Notification Procedure for Complementary and Herbal Medicinal Products.
TAMV, Ordinance on Veterinary Medicinal Products
AWV, Ordinance on the Advertising of Medicinal Products
MedDO, Medical Devices Ordinance
TPITO, Ordinance on Integrity and Transparency in relation to Therapeutic Products
ISABV-V, Ordinance on the Information System for Antibiotics in Veterinary Medicine
GebV-Swissmedic, Ordinance of the Swiss Agency for Therapeutic Products on its Fees
Therapeutic Products Supervision Levy Ordinance, Ordinance on the Supervision Levy to the Swiss Agency for Therapeutic Products
AllergV, Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Authorization of Allergen Preparations
Narcotics Law
NarcA, Federal Act on Narcotics and Psychotropic Substances
BetmKV, Ordinance on the Control of Narcotics
BetmSV, Ordinance on Narcotic Drug Addiction and Other Addiction-Related Disorders
Health insurance law
KVG, Federal Act on Health Insurance
KVV, Ordinance on Health Insurance
VKL, Ordinance on the Determination of Costs and the Recording of Services by Hospitals, Birthing Centres and Nursing Homes under Health Insurance.
KLV, Ordinance of the FDHA on Benefits in Compulsory Health Insurance
Foodstuffs law
FSA, Federal Act on Foodstuffs and Utility Articles
LGV, Ordinance on Foodstuffs and Utility Articles
VLBE, Ordinance of the FDHA on Foodstuffs for Persons with Special Dietary Needs
VNem, Ordinance of the FDHA on Food Supplements
LIV, Ordinance of the FDHA on Food Information
Food V CH, Ordinance of the FDHA on Novel Foods
Human Research Law
HRA, Federal Act on Research involving Human Beings
HRO, Ordinance on Human Research with the Exception of Clinical Trials
ClinO, Ordinance on Clinical Trials with the exception of Clinical Trials of Medical Devices
ClinO-MD, Ordinance on Clinical Trials of Medical Devices
Privacy, Data protection law