VO-Form

Quality variation requiring approval

This form cannot be used for variations during ongoing initial authorisation procedures.

Authorisation no.:……
Product name(s):
…… / Dosage form(s):
……

When completing this form, please note the following:

  • In order to levy fees correctly, a difference is made between human medicines (synthetic drugs, biotechnological drugs, vaccines and blood products), veterinary medicines, complementary and herbal medicines, allergens and radiopharmaceuticals.
  • The criteria for classifying a quality variation requiring approval as “major” or “minor” are defined in the guidance document Variations related to quality changes requiring approval. For a variation, only the box for "major" or "minor" changes need be checked, but not both. If several parameters change for one type of variation (e.g. specifications of the finished product), e.g. if:

a) one major and one minor change are applied for, click only once the box for a "major" change.

b) three minor changes are applied for, click only once on the box for a "minor" change.

  • The text fields “Scope / justification for the change” and “Present” - “Proposed” must be completed. References to the documentation or codes internal to the firm are not sufficient. This form may be used to submit several applications for quality variations requiring approval at the same time.
  • Changes that are justified as “consequential” to a proposed variation requiring approval (consequential change) must be described in the text field "Consequential change“ and justified. To identify the variations precisely, the SAP number (taken from this form) must be stated for variations requiring approval. For variations requiring notification, please state the number in accordance with Annex 8, AMZV (Nos. 1 - 48). When defining the level of the variation, please note the following. When applying for a "minor quality variation" requiring approval, only a "minor quality variation" or a consequential variation requiring notification may follow, but not a "major quality variation”. All consequential changes are subject to the same deadlines as variations requiring approval, and no additional fee is charged.
  • „The box "Other quality changes" should only be checked if the variation does not apply to any of the other types of variation proposed: otherwise, the application will not comply with the formal requirements.
  • For grouped applications, only those variations relating to the grouped application can be submitted on the same form. The first page of the form should include all the authorisation numbers, product names and pharmaceutical forms concerned.

The undersigned confirms that the details provided are complete and correct:
(Company stamp of applicant)
……
Compulsory / Optional (additional signature)
Location, date:……
Signature:…………………………………….
Responsible person
First name:……
Surname:……
Position held:…… / Location, date:……
Signature:......
Additional person
First name……
Surname:……
Position held:……

QM-Ident:ZL302_00_001e_FO / V08 / wer, its / dts / 01.01.20151 / 57

Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12

VO-Form

Quality variation requiring approval

aCTIVE pharmaceutical ingredient

Manufacturer of the active pharmaceutical ingredient (HSWS)

Change in the manufacturer of a starting material / reagent / intermediate used in the manufacturing process of the active pharmaceutical ingredient or change in the manufacturer of the active pharmaceutical ingredient. Change to quality control testing sites of the active pharmaceutical ingredient. (EU B.I.a.1)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2090) / ☐ / (2248)
Veterinary medicines / ☐ / (2093) / ☐ / (2252)
Complementary and herbal medicines / ☐ / (2091) / ☐ / (2249)
Allergens / ☐ / (2836) / ☐ / (2250)
Radiopharmaceuticals / ☐ / (2092) / ☐ / (2251)
Advanced therapy products / ☐ / ☐ / (3004)
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Manufacturing process of the active pharmaceutical ingredient(HSPWS)

Change in the manufacturing process of the active pharmaceutical ingredient. (EU B.I.a.2)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2094) / ☐ / (2253)
Veterinary medicines / ☐ / (2097) / ☐ / (2256)
Complementary and herbal medicines / ☐ / (2095) / ☐ / (2254)
Allergens / ☐ / (2837) / ☐ / (2852)
Radiopharmaceuticals / ☐ / (2096) / ☐ / (2255)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Batch size of active pharmaceutical ingredient (CHWS)

Change in batch size (including batch size ranges) of active pharmaceutical ingredient or intermediate used in the manufacturing process of the active pharmaceutical ingredient. (EU B.I.a.3)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2098) / ☐ / (2257)
Veterinary medicines / ☐ / (2102) / ☐ / (2261)
Complementary and herbal medicines / ☐ / (2099) / ☐ / (2258)
Allergens / ☐ / (2100) / ☐ / (2259)
Radiopharmaceuticals / ☐ / (2101) / ☐ / (2260)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

In-process tests of the active pharmaceutical ingredient (IPCWS)

Change to in-process tests or limits applied during the manufacture of the active pharmaceutical ingredient. (EU B.I.a.4)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2103) / ☐ / (2262)
Veterinary medicines / ☐ / (2107) / ☐ / (2266)
Complementary and herbal medicines / ☐ / (2104) / ☐ / (2263)
Allergens / ☐ / (2105) / ☐ / (2264)
Radiopharmaceuticals / ☐ / (2106) / ☐ / (2265)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Annual Update Influenza Vaccine (AUI)

Changes to the active pharmaceutical ingredient of a seasonal vaccine against human influenza. (EU B.I.a.5)

major / SAP Nr.
Human Medicines / ☐ / (2108)
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Specifications of the active pharmaceutical ingredient (SPWS)

Change in the specification parameters and/or limits of an active pharmaceutical ingredient, starting material / intermediate / reagent used in the manufacturing process of the active pharmaceutical ingredient. (EU B.I.b.1)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2109) / ☐ / (2267)
Veterinary medicines / ☐ / (2113) / ☐ / (2271)
Complementary and herbal medicines / ☐ / (2110) / ☐ / (2268)
Allergens / ☐ / (2111) / ☐ / (2269)
Radiopharmaceuticals / ☐ / (2112) / ☐ / (2270)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Test procedures for the active pharmaceutical ingredient (PMWS)

Change in test procedures for active pharmaceutical ingredient or starting material/reagent/intermediate used in the manufacturing process of the active pharmaceutical ingredient. (EU B.I.b.2)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2114) / ☐ / (2272)
Veterinary medicines / ☐ / (2118) / ☐ / (2276)
Complementary and herbal medicines / ☐ / (2115) / ☐ / (2273)
Allergens / ☐ / (2116) / ☐ / (2274)
Radiopharmaceuticals / ☐ / (2117) / ☐ / (2275)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Immediate packaging of the active pharmaceutical ingredient (PVWS)

Change in immediate packaging of the active pharmaceutical ingredient. (EU B.I.c.1)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2119) / ☐ / (2277)
Veterinary medicines / ☐ / (2121) / ☐ / (2279)
Complementary and herbal medicines / ☐ / (2120) / ☐ / (2278)
Allergens / ☐ / (2838) / ☐ / (2853)
Radiopharmaceuticals / ☐ / (2839) / ☐ / (2854)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Specifications of the immediate packaging of the active pharmaceutical ingredient (SPPVWS)

Change in the specification parameters and/or limits of the immediate packaging of the active pharmaceutical ingredient. (EU B.I.c.2)

minor / SAP Nr.
Human Medicines / ☐ / (2280)
Veterinary medicines / ☐ / (2284)
Complementary and herbal medicines / ☐ / (2281)
Allergens / ☐ / (2282)
Radiopharmaceuticals / ☐ / (2283)
Advanced therapy products / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Test procedures for the immediate packaging of the active pharmaceutical ingredient (PMPVWS)

Change in test procedures for the immediate packaging of the active pharmaceutical ingredient. (EU B.I.c.3)

minor / SAP Nr.
Human Medicines / ☐ / (2285)
Veterinary medicines / ☐ / (2289)
Complementary and herbal medicines / ☐ / (2286)
Allergens / ☐ / (2287)
Radiopharmaceuticals / ☐ / (2288)
Advanced therapy products / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Stability of the active pharmaceutical ingredient (STWS)

Change in the re-test period/storage period or storage conditions of the active pharmaceutical ingredient. (EU B.I.d.1)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2122) / ☐ / (2290)
Veterinary medicines / ☐ / (2125) / ☐ / (2293)
Complementary and herbal medicines / ☐ / (2123) / ☐ / (2291)
Allergens / ☐ / (2124) / ☐ / (2292)
Radiopharmaceuticals / ☐ / (2840) / ☐ / (2855)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Design Space for the active pharmaceutical ingredient (DSWS)

Introduction of a new design space or extension of an approveddesign space. (EU B.I.e.1)

major / SAP Nr.
Human Medicines / ☐ / (2126)
Veterinary medicines / ☐ / (2129)
Complementary and herbal medicines / ☐ / (2127)
Allergens / ☐ / (2841)
Radiopharmaceuticals / ☐ / (2128)
Advanced therapy products / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Introduction of a Change Management Protocol related to the active pharmaceutical ingredient (ECMPWS)

Introduction of a post approval change management protocol. (EU B.I.e.2)

major / SAP Nr.
Human Medicines / ☐ / (2130)
Veterinary medicines / ☐ / (2134)
Complementary and herbal medicines / ☐ / (2131)
Allergens / ☐ / (2132)
Radiopharmaceuticals / ☐ / (2133)
Advanced therapy products / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Deletion of a Change Management Protocol related to the active pharmaceutical ingredient (SCMPWS)

Deletion of an approved change management protocol. (EU B.I.e.3)

minor / SAP Nr.
Human Medicines / ☐ / (2938)
Veterinary medicines / ☐
Complementary and herbal medicines / ☐
Allergens / ☐
Radiopharmaceuticals / ☐
Advanced therapy products / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Changes to a Change Management Protocol related to the active pharmaceutical ingredient (CMPWS)

Changes to an approved change management protocol. (EU B.I.e.4)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2933) / ☐ / (2939)
Veterinary medicines / ☐ / ☐
Complementary and herbal medicines / ☐ / ☐
Allergens / ☐ / ☐
Radiopharmaceuticals / ☐ / ☐
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Implementation of a Change Management Protocol related to the active pharmaceutical ingredient (ICMPWS)

Implementation of changes foreseen in an approved change management protocol. (EU B.I.e.5)

minor / SAP Nr.
Human Medicines / ☐ / (2940)
Veterinary medicines / ☐
Complementary and herbal medicines / ☐
Allergens / ☐
Radiopharmaceuticals / ☐
Advanced therapy products / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Finished product

Markings of the finished product (KFP)

Change or addition of imprints, bossing or other markings including replacement, or addition of inks used for product marking. (EU B.II.a.1)

minor / SAP Nr.
Human Medicines / ☐ / (2294)
Veterinary medicines / ☐ / (2298)
Complementary and herbal medicines / ☐ / (2295)
Allergens / ☐ / (2296)
Radiopharmaceuticals / ☐ / (2297)
Advanced therapy products / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Shape / dimensions of the finished product (FFP)

Change in the shape or dimensions of the pharmaceutical form. (EU B.II.a.2)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2934) / ☐ / (2299)
Veterinary medicines / ☐ / ☐ / (2303)
Complementary and herbal medicines / ☐ / ☐ / (2300)
Allergens / ☐ / ☐ / (2301)
Radiopharmaceuticals / ☐ / ☐ / (2302)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Composition of the finished product (ZSFP)

Changes in the composition (excipients) of the finished product. (EU B.II.a.3)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2135) / ☐ / (2304)
Veterinary medicines / ☐ / (2139) / ☐ / (2308)
Complementary and herbal medicines / ☐ / (2136) / ☐ / (2305)
Allergens / ☐ / (2137) / ☐ / (2306)
Radiopharmaceuticals / ☐ / (2138) / ☐ / (2307)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Weight of coating / capsule of the finished product (GFP)

Change in coating weight of oral dosage forms or change in weight of capsule shells. (EU B.II.a.4)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2140) / ☐ / (2309)
Veterinary medicines / ☐ / (2144) / ☐ / (2313)
Complementary and herbal medicines / ☐ / (2141) / ☐ / (2310)
Allergens / ☐ / (2142) / ☐ / (2311)
Radiopharmaceuticals / ☐ / (2143) / ☐ / (2312)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Concentration of a parenteral finished product (KPFP)

Change in concentration of a single-dose, total use parenteral product, where the amount of active pharmaceutical ingredient per unit dose (i.e. the strength) remains the same. (EU B.II.a.5)

major / SAP Nr.
Human Medicines / ☐ / (2145)
Veterinary medicines / ☐ / (2149)
Complementary and herbal medicines / ☐ / (2146)
Allergens / ☐ / (2147)
Radiopharmaceuticals / ☐ / (2148)
Advanced therapy products / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Deletion of the solvent container of the finished product (LFP)

Deletion of the solvent / diluent container from the pack. (EU B.II.a.6)

minor / SAP Nr.
Human Medicines / ☐ / (2314)
Veterinary medicines / ☐ / (2318)
Complementary and herbal medicines / ☐ / (2315)
Allergens / ☐ / (2316)
Radiopharmaceuticals / ☐ / (2317)
Advanced therapy products / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Manufacturing site of the finished product (HSFP)

Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished product. (EU B.II.b.1)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2150) / ☐ / (2319)
Veterinary medicines / ☐ / (2153) / ☐ / (2322)
Complementary and herbal medicines / ☐ / (2151) / ☐ / (2320)
Allergens / ☐ / (2842) / ☐ / (2856)
Radiopharmaceuticals / ☐ / (2152) / ☐ / (2321)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Quality control testing / batch release of the finished product (QFP)

Change to importer batch release arrangements and quality control testing of the finished product. (EU B.II.b.2)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2154) / ☐ / (2323)
Veterinary medicines / ☐ / (2158) / ☐ / (2327)
Complementary and herbal medicines / ☐ / (2155) / ☐ / (2324)
Allergens / ☐ / (2156) / ☐ / (2325)
Radiopharmaceuticals / ☐ / (2157) / ☐ / (2326)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Manufacturing process of the finished product (HSPFP)

Change in the manufacturing process of the finished product including an intermediate used in the manufacture of the finished product. (EU B.II.b.3)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2159) / ☐ / (2328)
Veterinary medicines / ☐ / (2162) / ☐ / (2331)
Complementary and herbal medicines / ☐ / (2160) / ☐ / (2329)
Allergens / ☐ / (2843) / ☐ / (2857)
Radiopharmaceuticals / ☐ / (2161) / ☐ / (2330)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Batch size of the finished product (CHFP)

Change in the batch size (including batch size ranges) of the finished product. (EU B.II.b.4)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2163) / ☐ / (2332)
Veterinary medicines / ☐ / (2167) / ☐ / (2336)
Complementary and herbal medicines / ☐ / (2164) / ☐ / (2333)
Allergens / ☐ / (2165) / ☐ / (2334)
Radiopharmaceuticals / ☐ / (2166) / ☐ / (2335)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

In-process tests of the finished product (IPCFP)

Change to in-process tests or limits applied during the manufacture of the finished product. (EU B.II.b.5)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2168) / ☐ / (2337)
Veterinary medicines / ☐ / (2172) / ☐ / (2341)
Complementary and herbal medicines / ☐ / (2169) / ☐ / (2338)
Allergens / ☐ / (2170) / ☐ / (2339)
Radiopharmaceuticals / ☐ / (2171) / ☐ / (2340)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Specifications of an excipient (SPHS)

Change in the specification parameters and/or limits of an excipient. (EU B.II.c.1)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2173) / ☐ / (2342)
Veterinary medicines / ☐ / (2177) / ☐ / (2346)
Complementary and herbal medicines / ☐ / (2174) / ☐ / (2343)
Allergens / ☐ / (2175) / ☐ / (2344)
Radiopharmaceuticals / ☐ / (2176) / ☐ / (2345)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Test procedures for an excipient (PMHS)

Change in test procedures for an excipient. (EU B.II.c.2)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2178) / ☐ / (2347)
Veterinary medicines / ☐ / (2182) / ☐ / (2351)
Complementary and herbal medicines / ☐ / (2179) / ☐ / (2348)
Allergens / ☐ / (2180) / ☐ / (2349)
Radiopharmaceuticals / ☐ / (2181) / ☐ / (2350)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Source of an excipient (HHS)

Change in source of an excipient or reagent with TSE risk. (EU B.II.c.3)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2183) / ☐ / (2352)
Veterinary medicines / ☐ / (2187) / ☐ / (2356)
Complementary and herbal medicines / ☐ / (2184) / ☐ / (2353)
Allergens / ☐ / (2185) / ☐ / (2354)
Radiopharmaceuticals / ☐ / (2186) / ☐ / (2355)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Synthesis of an excipient (SHS)

Change in synthesis or recovery of a non-pharmacopoeial excipient (when described in the dossier) or a novel excipient. (EU B.II.c.4)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2188) / ☐ / (2357)
Veterinary medicines / ☐ / (2192) / ☐ / (2361)
Complementary and herbal medicines / ☐ / (2189) / ☐ / (2358)
Allergens / ☐ / (2190) / ☐ / (2359)
Radiopharmaceuticals / ☐ / (2191) / ☐ / (2360)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change

Quality variation requiring approval SAP Nr.:……

Variations requiring notification Nr.:……

Scope / justification for the change
……
Present / Proposed
…… / ……

Specifications of the finished product (SPFP)

Change in the specification parameters and/or limits of the finished product. (EU B.II.d.1)

major / SAP Nr. / minor / SAP Nr.
Human Medicines / ☐ / (2193) / ☐ / (2362)
Veterinary medicines / ☐ / (2196) / ☐ / (2365)
Complementary and herbal medicines / ☐ / (2194) / ☐ / (2363)
Allergens / ☐ / (2844) / ☐ / (2858)
Radiopharmaceuticals / ☐ / (2195) / ☐ / (2364)
Advanced therapy products / ☐ / ☐ /
Scope / justification for the change
……
Present / Proposed
…… / ……

Consequential change