(Art. 8 para. 1–3)
The risk factor should always be calculated for a particular medicinal product. If the multiplication of the factors in number 2 produces a figure below 100, a cantonal manufacturing licence is required instead of a Swissmedic licence.
| Factor | |
|---|---|
| 1. Administration route: | |
| a. parenteral administration | 5 |
| b. ophthalmological administration in surgery or for traumatic injuries | 4 |
| c. inhaled administration | 4 |
| d. enteral or topical administration with requirements for sterility | 4 |
| e. enteral administration | 3 |
| f. ophthalmological administration in the uninjured eye | 1 |
| g. topical administration | 1 |
| 2. Annual production quantity: | |
| a. liquid dosage forms in standard pack units or application units in litres | |
| 1. more than 2,000 | 5 |
| 2. 1000–2000 | 4 |
| 3. 500–999 | 3 |
| 4. 100–499 | 2 |
| 5. less than 100 | 1 |
| b. solid dosage forms, number of units | |
| 1. more than 120,000 | 5 |
| 2. 60,000–120,000 | 4 |
| 3. 30,000–59,999 | 3 |
| 4. 6,000–29,999 | 2 |
| 5. less than 6000 | 1 |
| c. semi-solid dosage forms (suppositories), number of units | |
| 1. more than 40,000 | 5 |
| 2. 20,000–40,000 | 4 |
| 3. 10,000–19,999 | 3 |
| 4. 2000–9999 | 2 |
| 5. less than 2000 | 1 |
| d. semi-solid dosage forms (ointments, creams, etc.) in grams | |
| 1. more than 200,000 | 5 |
| 2. 100,000–200,000 | 4 |
| 3. 50,000–99,999 | 3 |
| 4. 10,000–49,999 | 2 |
| 5. less than 10,000 | 1 |
| e. eye drops in litres | |
| 1. more than 200 | 5 |
| 2. 100–200 | 4 |
| 3. 50–99 | 3 |
| 4. 10–49 | 2 |
| 5. less than 10 | 1 |
| 3. Inherent risks of the active ingredient: | |
| a. high risk | 5 |
| b. medium risk | 3 |
| c. low risk | 1 |
| The following criteria at least are assessed in classifying the risk of an active ingredient: carcinogenicity, mutagenicity, environmental toxicity, allergy risk, therapeutic range, dosage unit, stability (light, oxygen, temperature, pH changes), pharmaceutical quality, pharmacopoeial conformity. | |
| 4. Manufacturing process: | |
| a. aseptic manufacture | 5 |
| b. manufacture with terminal sterilisation | 4 |
| c. dissolving and mixing | 3 |
| d. diluting | 2 |
| e. filling of non-sterile dosage forms | 1 |
| 5. Quantitative ratios: contract manufactured medicinal products – medicinal products manufactured for dispensing to own customers: | |
| a. exclusively contract manufacture | 5 |
| b. mainly contract manufacture (ratio: around 2:1) | 4 |
| c. balanced (ratio: around 1:1) | 3 |
| d. mainly for own customers (ratio: around 1:2) | 2 |
| e. exclusively for own customers | 0.2 |
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