Fields of law
We offer companies from the pharmaceutical and food industries as well as people and organizations active in the healthcare sector quick and uncomplicated practical solutions at competitive prices.
Information about our specialties
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Authorisations
Regulatory questions about authorisations, exceptions, and specificities (formula drugs, Fast Track, Article 13 Therapeutic Products Act).
Orphan Drugs
Orphan drugs und compassionate use, requirements, and admissibility
Off Label Use
Limits and possibilities
Pharmacovigilance, market supervision
Technical responsibility and reporting obligations
Distribution and dispensing
Dispensing categories, mail order, self-dispensing
Advertising and communication
Advertising to professionals and to the general public, advertising and information, internet
Monetary advantages
Discounts, retrocessions, Pharma Cooperation Code, donations, events sponsorship, service contracts
Parallel imports
Requirements for parallel imports
First filing protection
Duration of protection, generics.
Delimitations
Distinctions from medical devices, food supplements, cosmetics
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Ethics Committees, FOPH, Swissmedic
Research with medicinal products for human use, licensing requirements, cooperation with ethics committees, FOPH and Swissmedic
GCP
Division of tasks Investigator, Sponsor; Investigator initiated Studies
Non Interventional Studies
Non-interventional studies, reports on practical experience, usage observations
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Manufacturing, wholesale, retail, GMP, GDP outpatient medical institutions, self-dispensing
Outpatient medical institutions, self-dispensation
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Specialist and public advertising campaigns
Consulting, expert opinions, including in 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
Pharmacode and Pharma Cooperation Code
Content and scope of application, relationship with the Therapeutic Products Act, disclosure, prohibition of gifts
Sample
Trade samples, samples for the public, advertising with samples
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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, obligation to notify
Technical documentation, conformity assessment offices, technical standards, CE-certification label
Market supervision
Materials vigilance, product monitoring, advertising
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General reimbursement issues with the specialty drug list (SDL), list of specialty drugs for birth defects (GGML), list of therapeutic products and medical devices (MiGeL)
Reimbursement of drugs for unapproved usage and limitations (off-label/off-limitation use) or outside the SDL (non-SDL)
Review of authorisation conditions (price review)
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Professional licence requirements
Rights and obligations in connection with drugs (usage, dispensing, self-dispensing)
Regulatory aspects concerning permissible activities, scope of practice
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Requirements for the collection of medical data
Communication 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
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Delimitations
Delimitation in respect of therapeutic products and medicinal products
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 on the Simplified Authorization of Medicinal Products and the Authorization of Medicinal Products in 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
MepV, 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 Therapeutic Products Institute
AllergV, Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Authorization of Allergen Preparations
Narcotics Law
Health insurance law
KVG, Federal Law on Health Insurance
KVV, Ordinance on Health Insurance
VKL, Ordinance on Cost Determination and Service Recording by Hospitals, Maternity Hospitals and Nursing Homes in Health Insurance.
KLV, Ordinance on Benefits in Compulsory Health Insurance
Foodstuffs law
FSA, Federal Act on Foodstuffs and Utility Articles
LGV, Foodstuffs and Utility Articles Ordinance
VLBE, Ordinance on Food for Persons with Special Dietary Needs.
VNem Regulation on food supplements
LIV, Ordinance on Food Information
Novel Food V CH, Ordinance 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 with Medical Devices
Privacy, data protection law