Glossary: Swiss therapeutic products law from A to Z

Terms from the TPA, TPO, MPLO and everyday Swissmedic practice, each explained in two to four sentences. Every entry has its own anchor and is marked up as DefinedTerm.

69 terms

A

Access Consortium: Coalition of the medicines regulators of Australia, Canada, Singapore, the United Kingdom and Switzerland. It enables work-sharing assessments on a coordinated timetable; the decisions remain national.
AIPS: Swissmedic's medicinal product information publication system. It contains the approved prescribing information and patient information for all medicinal products authorised in Switzerland and is accessible at swissmedicinfo.ch.
Art. 13 TPA: Provision under which Swissmedic gives due consideration to the assessment results of an authority with comparable medicinal product control if the product is already authorised there. It is not automatic recognition.
Art. 45 TPO: Provision that allows pharmacists to dispense certain category B medicinal products without a prescription, provided they give personal advice and document the dispensing.
ATC code: WHO Anatomical Therapeutic Chemical classification. It groups active substances by organ system and mechanism of action and supports comparability across markets.
Authorisation number: Number assigned by Swissmedic that uniquely identifies an authorisation. It appears on the pack and in the medicinal product information and is cited in every submission.

B

BASEC: Electronic submission portal of the Swiss ethics committees for research projects involving human subjects. Applications, amendments and reports are all handled through BASEC.
Batch recall: Withdrawal of a specific batch from the market because of a quality or safety problem. The marketing authorisation holder initiates it, and Swissmedic supervises and publishes it.
Batch release: Decision by the Responsible Person that a batch meets specification and may be placed on the market. Documented release is required for every batch.
Bioequivalence: Demonstration that two medicinal products produce comparable active substance concentrations in the blood after administration of the same dose. It is the basis for authorising a generic.
Biosimilar: Biological medicinal product that is highly similar to an authorised biological reference product. Comparability is demonstrated stepwise through analytical, preclinical and clinical data.

C

CH-REP: Authorised representative established in Switzerland for a foreign medical device manufacturer. They keep the technical documentation available and act as Swissmedic's point of contact.
Clinical Trials Ordinance (KlinV): Clinical Trials Ordinance (SR 810.305). It governs categories, authorisation procedures, reporting obligations and safety reports for clinical trials.
Co-marketing medicinal product: Medicinal product that is identical to an authorised base product and is marketed only under a different name. It is authorised through the notification procedure under Art. 15 TPA.
Compassionate use: Use of an unauthorised medicinal product in patients with a serious disease and no therapeutic alternative, handled in Switzerland via the temporary permit under Art. 9b TPA.
CTD: Common Technical Document, the internationally harmonised dossier format in five modules. Modules 2 to 5 are international, Module 1 is country-specific.

D

Dispensing category: Classification of a medicinal product under Art. 40 et seq. TPO that determines who may dispense it and whether a prescription is required. There are categories A, B, D and E; the former category C was abolished in 2019.
Dossier: The complete set of documents in a marketing authorisation application. It covers quality, preclinical and clinical data, summaries, and the regional information in Module 1.

E

eCTD: Electronic form of the CTD with a defined folder structure, sequence numbering and lifecycle operations. It is the preferred submission format at Swissmedic.
ELViS: Swissmedic's Electronic Vigilance System. Healthcare professionals and marketing authorisation holders use it to report adverse drug reactions and quality defects.
Establishment licence: Authorisation from Swissmedic for activities involving medicinal products such as manufacturing, wholesale dealing, import or export. It names the sites, activities, product categories and the Responsible Person.
Ethics committee: Cantonal committee that authorises research projects involving human subjects. No trial participant may be enrolled in a clinical trial without its authorisation.

F

Fedlex: The Confederation's official publication platform for legislation. Only the versions published there in German, French or Italian are legally binding.
Fee Ordinance: Ordinance on the fees charged by the Swiss Agency for Therapeutic Products. It sets procedural fees, hourly rates and the annual fee per authorisation.
First applicant protection: Protection of an originator's authorisation documentation under Art. 11a and 11b TPA. It runs for ten years for a new active substance and three years for a new indication.
FOPH: Federal Office of Public Health. It decides on the inclusion of medicinal products in the Specialities List, on prices and on the reimbursement obligation of mandatory health insurance.
Formula magistralis: Preparation compounded by a pharmacy for a specific person on medical prescription. It is exempt from the authorisation requirement under Art. 9 TPA.
Formula officinalis: Preparation compounded by a pharmacy according to a pharmacopoeia or its own formula for its own customers. It is exempt from the authorisation requirement within the statutory limits.

G

GCP: Good Clinical Practice, the international standard for the design, conduct and reporting of clinical trials. It protects participants and safeguards data quality.
GDP: Good Distribution Practice for the wholesale dealing and distribution of medicinal products. Core topics are temperature control, traceability, supplier qualification and recall processes.
Generic medicinal product: Medicinal product that is essentially the same as an authorised medicinal product and relies on its documentation under Art. 12 TPA. It requires proof of bioequivalence.
GMP: Good Manufacturing Practice for medicinal products. It covers the quality system, personnel, premises, documentation, production, quality control and self-inspection; the PIC/S guide is the underlying basis.

H

Human Research Act (HRA, HFG): Human Research Act (SR 810.30). It governs research involving human subjects, information and consent, the licensing requirement and the role of the ethics committees.

I

ICH: International Council for Harmonisation. The body develops the guidelines on quality, safety, efficacy and multidisciplinary topics that Swissmedic applies.
In Vitro Diagnostics Ordinance (IvDV): Ordinance on in vitro diagnostic medical devices. It governs laboratory and self-tests analogous to the European IVDR and complements the Medical Devices Ordinance.
Indication: The field of application for which a medicinal product is authorised. The wording is part of the decision; use outside it is off-label use.
Inspection: On-site regulatory check of an establishment for compliance with GMP or GDP. Swissmedic and the regional inspectorates are responsible; findings are classified by severity.

L

List of Questions: Catalogue of questions that Swissmedic issues after an assessment phase. The time the applicant needs to answer stops the regulatory clock and extends the overall procedure duration.

M

MAH: Marketing Authorisation Holder. In Switzerland it must have a registered office, branch or domicile in the country and bears the pharmacovigilance obligations.
Manufacturing licence: Establishment licence for manufacturing activities, including packaging, labelling, testing and batch release. It requires a GMP-compliant quality system.
Marketing authorisation holder: The company in whose name an authorisation is held. It must have a Swiss domicile, bears the pharmacovigilance obligations and is the addressee of all Swissmedic decisions.
Medical Devices Ordinance (MedDO, MepV): Medical Devices Ordinance (SR 812.213). It governs requirements, classification, conformity assessment and the obligations of economic operators, and is modelled on the EU MDR.
Medicinal product information: Combination of the prescribing information for healthcare professionals and the patient information for users. It is part of the authorisation decision and must be available in German, French and Italian.
Medicinal Products Authorisation Requirements Ordinance (AMZV): Ordinance on the requirements for the authorisation of medicinal products (SR 812.212.22). It sets out the content requirements for the authorisation dossier and for the medicinal product information.
Medicinal Products Licensing Ordinance (MPLO, AMBV): Medicinal Products Licensing Ordinance (SR 812.212.1). It governs establishment licences for manufacturing, wholesale dealing, import and export, and the requirements for the Responsible Person.

N

Narcotics Act (BetmG): Narcotics Act (SR 812.121). It governs controlled substances, the related licences, record-keeping, and import and export on a per-consignment basis.
New marketing authorisation: First-time authorisation of a medicinal product in Switzerland. It requires a complete dossier and takes around 330 days of regulatory time under the standard procedure.
Notification procedure: Simplified procedure under Art. 15 TPA for certain constellations, such as co-marketing. Swissmedic checks identity and formalities rather than re-assessing quality, safety and efficacy.

O

Off-label use: Use of an authorised medicinal product outside the approved indication, dosage or population. Responsibility lies with the prescriber; reimbursement is governed by Art. 71a et seq. of the Health Insurance Ordinance.
Ordinance on the Simplified Authorisation of Medicinal Products (VAZV): Ordinance on the simplified authorisation of medicinal products (SR 812.212.23). It governs special routes for complementary medicinal products, orphan drugs and the notification procedure.
Orphan drug: Medicinal product for a rare disease. The status brings relief in the simplified authorisation procedure and on fees, plus an extended protection period.

P

Parallel import: Import by a third party of a medicinal product authorised in Switzerland from another market. It requires a simplified authorisation and, because the product is repackaged, a manufacturing licence.
Patient information: The part of the medicinal product information intended for users, in lay-accessible language. It is included with the pack and published via AIPS.
Periodic safety update report: Regular comprehensive evaluation of a medicinal product's benefit-risk profile by the marketing authorisation holder. The frequency is set in the decision or in the applicable requirements.
Pharmacovigilance: Monitoring of medicinal product safety after authorisation. It covers case reports, signal management, periodic safety reports and risk minimisation measures.
PIC/S: Pharmaceutical Inspection Co-operation Scheme. This international network harmonises GMP and GDP inspections and builds mutual trust among member authorities.
Prescribing information: The part of the medicinal product information intended for healthcare professionals, covering indication, dosage, contraindications, warnings and pharmacological data. Its EU counterpart is the SmPC.
Procedure with pre-notification: Procedure under Art. 6 TPO in which the application is pre-notified with a binding submission date. Swissmedic reserves assessment capacity and shortens the regulatory time.

R

Responsible Person (FvP): Specialist named in the licensing decision who is responsible for compliance with GMP or GDP. They decide independently on technical matters and release batches.
Risk management plan: Document that describes a medicinal product's known and potential risks and sets out measures to monitor and minimise them. It is part of the authorisation dossier.

S

Specialities List (SL): The FOPH's list of medicinal products covered by mandatory health insurance, with their prices and limitations. It governs reimbursement, not authorisation; LS in French, ES in Italian.
Sunset clause: Rule under Art. 16a TPA under which an authorisation lapses if the medicinal product is not placed on the market within three years of authorisation or is no longer on the market for three years.
swissdamed: Swiss database for medical devices and their economic operators. It is the Swiss counterpart to the European database EUDAMED.
Swissmedic: Swiss Agency for Therapeutic Products, the national authorisation and supervisory authority for medicinal products and medical devices. It is based at Hallerstrasse 7, 3012 Bern.
Swissmedic Journal: The Agency's official publication. It lists new authorisations, renewals, revocations, changes to the dispensing category and other notices.

T

Temporary authorisation: Authorisation subject to conditions under Art. 9a TPA for medicinal products with as yet incomplete data, granted for a serious disease with no equivalent alternative. It is time-limited and intended to be converted into an ordinary authorisation.
Therapeutic Products Act (TPA, HMG): Therapeutic Products Act (SR 812.21), the federal act on medicinal products and medical devices. It is the framework act of Swiss therapeutic products law; the short form is LPTh in French and LATer in Italian.
Therapeutic Products Ordinance (TPO, VAM): Therapeutic Products Ordinance (SR 812.212.21). It governs authorisation procedures, timelines, variations, dispensing categories and pharmacovigilance; OMéd in French, OM in Italian.

W

Wholesale dealing: Procuring, storing, supplying or delivering medicinal products to persons entitled to resell or use them. It requires a licence.

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