Swissmedic Clarifies GMP Requirements for Formula Drugs
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The Swissmedic recently clarified some requirements for the manufacture and marketing of formula drugs (e.g. "Formula magistralis" medicinal products) by issuing an updated version of their corresponding guidance document. Formula drugs are medicinal products that do not require a marketing authorization. The guideline is the basis for "GMP inspections for formula drugs" (i.e., Good Manufacturing Practice for Medicinal Products manufactured in Small Quantities) carried out by the cantonal inspectorates and Swissmedic.
Types of Formula Medicinal Products
- Formula magistralis
"Formula magistralis" medicinal products are manufactured on the basis of a medical or veterinary prescription. Manufacture must take place in a public pharmacy or hospital pharmacy that is authorized to manufacture in accordance with the TPA (Swiss Therapeutic Products Act). Other manufacturing facilities are authorized to manufacture on a contract basis for pharmacies/hospital pharmacies if they have a corresponding manufacturing authorization from Swissmedic (an overview of the necessary manufacturing licenses can be found in the table provided below). - Formula officinalis
"Formula officinalis" manufacture is carried out according to a special official monograph of the Pharmacopoeias (i.e. European Pharmacopoeia (Ph. Eur.) and Swiss Pharmacopoeia (Ph. Helv.) or another pharmacopoeia recognized by Swissmedic. The law also grants Swissmedic the authority to recognize a Formulary prepared by private companies (Swissmedic has recently authorized a preparation monograph from a private company). - Own-formula medicinal products
Own-formula medicinal products are exclusively non-prescription medicinal products that are manufactured at the facility according to a proprietary formula or a formula published in public literature. Own-formula medicinal products are manufactured ad hoc or by compounding. They may be manufactured by the persons listed in the TPA (Article 25), who are authorized to dispense to their own customers. In addition to federal law, cantonal law must also be taken into account. For this reason, companies are well advised to contact the responsible cantonal health authorities (cantonal pharmacist or competent authority) before placing the product on the market and to inquire about any additional applicable regulations. Further information on the recognized formulas can be found in the updated Positive list (e.g. DAC / NRF "German National Formulary" which includes, for example, several medical Cannabis preparations). - Formula hospitalis
The term "Formula hospitalis" describes medicinal products for which it can be proven that no alternative and equivalent medicinal product is authorized or available in Switzerland. They may be compounded in a hospital pharmacy only. The hospital must keep a list of all medicinal products manufactured in accordance with the hospital formulary ("hospital list") and regularly check the legality of the manufacture, in particular whether no comparable medicinal product is authorized in Switzerland. There is no quantitative restriction on the manufacture of medicinal products according to "Formula hospitalis".
Overview of required Manufacturing Licenses for Formula Medicinal Products
| Activity | Issuing Competent Authority |
| Manufacture of a formulated medicinal product by a facility authorized to dispense it | Depending on the result of an assessment (the cantons or Swissmedic) |
| Contract manufacturing of formulated medicinal products including intermediate and bulk products by a facility authorized to dispense them | Depending on the result of an assessment (the cantons or Swissmedic) |
| Contract manufacturing of formula medicinal products including intermediate and bulk products by a facility not authorized to dispense them | Swissmedic |
| Contract manufacturing of formula medicines (including intermediate and bulk products) abroad | Competent authority recognized by Switzerland within the MRA framework (Mutual Recognition Agreement) with regard to GMP (it must be clear from the facility license with the associated GMP certificate that the document also applies to the manufacturing area and the site where the contract manufacturing of the formula medicinal product in question takes place) |
| Assure the identity of the contents of each container of starting material in accordance with Ph. Helv. | Swissmedic |
More information is available in the updated Version 3.0 of the Swissmedic document Herstellung und Inverkehrbringen von Formula-Arzneimitteln published on the Swissmedic Inspectorates website.