Regulations 2, 3, 5, 6, 7 and 10
SCHEDULE 1U.K.Fees relating to applications for the grant, variation and renewal of marketing authorisations, product licences, manufacturer’s licences, wholesale dealer’s licences and animal test certificates
PART 1U.K.Interpretation
In this Schedule—
“abridged standard”, in relation to an application, describes an application for a marketing authorisation which, by virtue of regulation 4(8) of the 1994 Regulations, need not be accompanied by the results of tests and trials of the type specified in Article 13.1 of Directive 2001/82/EC but does not include a simple application or an emergency vaccine application;
“active ingredient” means the ingredient of a product in respect of which efficacy is claimed;
“Animal Test Certificate—Type A application” means an application for a certificate in relation to a medicinal test on animals under section 32 of the Act with respect to—
an immunological veterinary medicinal product which has been authorised in a Member State for use with species on whom the proposed test will be conducted;
a pharmaceutical veterinary medicinal product which has been authorised in a Member State for use with food-producing species on which the proposed test will be conducted where the same or a similar dosage regime and method of administration is to be used in the medicinal test as is authorised; or
a pharmaceutical medicinal product authorised in a Member State for human or animal use where the test is to be conducted on companion animals only;
“Animal Test Certificate—Type B application” means an application for a certificate under section 32 of the Act which does not fall within the definition for “Animal Test Certificate—Type A application”;
“Article 26.3 marketing authorisation” means an authorisation of the type provided for in Article 26.3 of Directive 2001/82/EC;
“biological product” includes an antigen, toxin, antitoxin, toxoid, serum, antiserum or vaccine or a fraction of any such product;
“Category I”, in relation to an application, describes an application for assistance in connection with a mutual recognition application other than a Category II or III application;
“Category II”, in relation to an application, describes an application, other than a Category III application, for assistance in connection with a mutual recognition application relating to a marketing authorisation granted in respect of a veterinary medicinal product only intended for administration to animals whose flesh or products are not intended for human consumption;
“Category III”, in relation to an application, describes an application for assistance in connection with a mutual recognition application relating to a marketing authorisation granted in respect of an immunological veterinary medicinal product;
“complex”, in relation to an application, describes an application for, or for a variation of, a marketing authorisation or product licence where the application—
relates to a product which is intended to be used—
in accordance with an indication for use in respect of a species of animal; or
as a treatment for a medicinal purpose,
for which it has not previously been used;
relates to a product containing a combination of active ingredients which have not previously been included in that combination in a product in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom;
relates to a product containing a new excipient;
relates to a product which is intended to be administered by a route of administration different from that used in the administration of any product—
which contains the same active ingredient as the product in question; and
in respect of which a marketing authorisation or a product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom;
relates to a sterile product the manufacture of which involves a method of sterilisation different from that used in the manufacture of any product—
which contains the same active ingredient as the product in question, and
in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom;
relates to a product containing an active ingredient the manufacture of which involves a route of synthesis (or, in the case of a product not synthetically produced, a method of manufacture) different from that used in the manufacture of the active ingredient of any product—
which contains the same active ingredient as the product in question; and
in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom;
relates to a biological product containing an active ingredient, the manufacture of which involves a growth substrate different from that used in the manufacture of the active ingredient of any product—
which contains the same active ingredient as the product in question; and
in respect of which a marketing authorisation or product licence has previously been granted in the United Kingdom;
relates to a product which is a controlled release preparation in circumstances where a marketing authorisation or product licence for animal use (other than a product licence of right) for such a preparation containing the same active ingredient as the product in question has not previously been granted in the United Kingdom;
relates to a container directly in contact with a sterile product, that container being made from a material different from that used for the container of any sterile product—
which contains the same active ingredient as the sterile product in question; and
in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom;
names as manufacturer of the active ingredient of the product in question a manufacturer different from the manufacturer of the active ingredient of any product—
which contains the same active ingredient as the product in question; and
in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom; or
relates to a biological product containing an active ingredient derived from a strain of micro-organism different from that used in the manufacture of the active ingredient of any product—
which contains the same active ingredient as the product in question; and
in respect of which a marketing authorisation or product licence has previously been granted in the United Kingdom,
but does not include a major application or an emergency vaccine application;
“emergency vaccine” means a vaccine manufactured or assembled only from material obtained from the particular animal, flock or herd intended to be vaccinated and in circumstances in which no suitable authorised or licensed vaccines are readily available and, in relation to an application, describes an application limited to use of an emergency vaccine, for a product licence;
“excipient”, in relation to an immunological veterinary medicinal product, includes an adjuvant;
“immunological veterinary medicinal product” has the same meaning as in Directive 2001/82/EC;
“individual variation” means, in relation to an application to vary (or renew with variations)—
a mutually recognised marketing authorisation, a change covered by any single numbered paragraph of Annex I to Regulation (EC) No 1084/2003;
any other authorisation or licence or certificate, a change to any element in the application which calls for a separate assessment in order to reach a decision whether the application should be granted;
“marketing authorisation (parallel import)” means a marketing authorisation granted by the relevant authority in respect of a veterinary medicinal product which—
is imported into the United Kingdom from an EEA State;
has been granted a marketing authorisation by an EEA State; and
has no therapeutic effect different from that of a veterinary medicinal product already granted a marketing authorisation in the United Kingdom;
“major”, in relation to an application, describes an application for a marketing authorisation or product licence in respect of a product containing a new active ingredient but does not include an emergency vaccine application;
“Member State” means a member State other than the United Kingdom;
“new active ingredient” means—
an active ingredient that has not previously been included as an active ingredient in a product in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom;
an active ingredient in a product where the product is derived from genetically engineered micro-organisms, recombinant DNA technology or monoclonal antibodies; or
in the case of a biological product, a vaccine of a particular micro-organism whether in a live or inactivated form, other than a vaccine of a particular micro-organism which is derived from a strain of micro-organism which is antigenetically similar to that used in the manufacture of the active ingredient of a product in respect of which a marketing authorisation or product licence (not being a product licence of right) has previously been granted in the United Kingdom;
“new excipient”, in relation to a product containing it, means any ingredient which—
is not an active ingredient;
has not previously been included in a product of a different description—
which is intended to be administered by the same route of administration as that of the product containing it; and
in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted; and
if the product containing it is intended to be administered orally, is not specified in any Act or subordinate legislation as a lawful ingredient of or additive for—
food for human consumption in any event; or
animal feedingstuffs, in any case where the product containing it is intended for administration after being incorporated in an animal feedingstuff;
“Reference Member State” has the meaning given by Article 3.4 of Regulation (EC) No 1084/2003;
“simple”, in relation to an application, describes an application for a marketing authorisation or product licence when the application—
is made by reference to an application for a particular product (“the existing product”) in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted;
is made with the permission of the marketing authorisation or licence holder for the existing product; and
relates to a product which is in all the following respects the same as the existing product:
the formulation is identical;
it is intended to be used in accordance with the same indications;
it is intended to be administered by the same route of administration;
the manufacturer is the same;
the method of manufacture is the same; and
in the case of a sterile product the method of sterilisation is the same and the container which is directly in contact with the product is made from the same material;
but does not include an emergency vaccine application;
“standard”, in relation to an application, describes an application which is not a major, complex, abridged standard or simple application;
“type A marketing authorisation” means an authorisation to which regulation 5(a) of the 1994 Regulations applies;
“type B marketing authorisation” means an authorisation to which regulation 5(b) of the 1994 Regulations applies;
“Type IA notification” means a variation of a mutually recognised marketing authorisation of a type listed in the Table in Annex I to Regulation (EC) No 1084/2003 in respect of which the note “IA” is entered in the final column of that Table;
“Type IB”, in relation to a variation, describes a variation of a mutually recognised marketing authorisation of a type listed in the Table in Annex I to Regulation (EC) No 1084/2003 in respect of which the note “IB” is entered in the final column of that Table; and
“Type II”, in relation to a variation, describes a variation of a mutually recognised marketing authorisation of the type referred to in Article 3.3 of Regulation (EC) No 1084/2003.
PART 2U.K.Fees Relating to Applications for the Grant of Marketing Authorisations, Product Licences, Manufacturer’s Licences, Wholesale Dealer’s Licences, Animal Test Certificates and Export Certificates
Marketing authorisations and product licencesU.K.
1. The fee for an application is that specified in the table below.U.K.
| Type of application | type A marketing authorisation(£) | type B marketing authorisation (£) | product licence (£) | Article 26.3 marketing authorisation (£) |
|---|---|---|---|---|
| Major | 22,270 | 12,285 | 22,270 | 12,920 |
| Complex | 12,920 | 7,375 | 12,920 | 5,580 |
| Standard | 5,580 | 3,690 | 5,580 | — |
| Abridged standard | 4,360 | — | — | — |
| Simple | 1,555 | 975 | 1,555 | — |
| Emergency vaccine | — | — | 40 | — |
2. Paragraph 1 shall not apply where an application for a marketing authorisation is made by a person who is already the holder of an Article 26.3 marketing authorisation relating to the same veterinary medicinal product as the marketing authorisation applied for, in which case the fee shall be—U.K.
(a)where a major application was previously made in respect of the Article 26.3 marketing authorisation, £9,350;
(b)where a complex application was previously made in respect of the Article 26.3 marketing authorisation, £7,340.
3.—(1) This paragraph applies to fees which would, but for this paragraph, be payable by reference to paragraph 1, whether or not as qualified by paragraph 2.U.K.
(2) Where a major or a complex application is made by a person who is already the holder of—
(a)an animal test certificate, in respect of a product containing the same active ingredient;
(b)a marketing authorisation or product licence covering export only, relating to the same product,
the fee shall be reduced by the amount of the application fee paid for that certificate or licence.
(3) Where an applicant has made an original request (that is to say a set of one or more applications where each product contains the same active ingredient or the same combination of active ingredients) and either—
(a)withdraws each application in the original request and substitutes for them a new application for one or more products containing the same active ingredients or combination of active ingredients as those in the original request; or
(b)withdraws some but not all of the applications in the original request,
then there shall be payable in respect of the new or (as the case may be) remnant applications the total of the fees which would have been charged for them had they alone comprised the original request, but there shall be allowed against it the net total of any fees paid in respect of the original request.
(4) Where an applicant has pending one or more major applications for a marketing authorisation or product licence and each product contains the same active ingredient or combination of active ingredients the fees payable shall be the fee for a major application under paragraph 1 in respect of the first application and for each additional application—
(a)which relates to a product of a different dosage form, the fee for a complex application under paragraph 1;
(b)which relates to a product of the same dosage form but of a different strength of any active ingredient, the fee for a standard application under paragraph 1.
(5) Where an applicant has pending one or more complex applications for a marketing authorisation or product licence and each product contains the same active ingredient or combination of active ingredients the fees payable shall be the fee for a complex application under paragraph 1 in respect of the first application and for each additional application—
(a)which relates to a product of a different dosage form, the fee for a standard application under paragraph 1;
(b)which relates to a product of the same dosage form but of a different strength of any active ingredient, the fee for a simple application under paragraph 1.
Manufacturer’s licencesU.K.
4.—(1) The fee for an application for a manufacturer’s licence shall be—U.K.
(a)in a case to which sub-paragraph (2) below applies, £110; or
(b)in any other case £2,505; and
(c)in either case, if appropriate, a fee calculated in accordance with Schedule 2 in respect of any inspection made in connection with that application.
(2) This sub-paragraph applies in the case of an application for a manufacturer’s licence which is limited solely to the manufacture or assembly of—
(a)products the sale or supply of which would require a product licence but for article 2(2)(i) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971(1); or
(b)emergency vaccines.
Wholesale dealer’s licencesU.K.
5.—(1) The fee for an application for a wholesale dealer’s licence is £1,455.U.K.
(2) Paragraph (1) does not apply where turnover in the first year of trading is less than £40,000 in which case the fee is £595 provided that payment is accompanied by an estimate of that year’s turnover.
(3) Following the first anniversary of the grant of a wholesale dealer’s licence, where a fee of £595 was paid, the holder shall, together with his payment of the next annual fee payable under regulation 11(1), send a declaration certifying his turnover for his first year of trading.
(4) If either a declaration, as required by sub-paragraph (3) above, is not sent or the declaration shows that turnover for the first calendar year of trading was £40,000 or more, the wholesale dealer shall pay the balance of £860 no later than 30 days after the first anniversary of the grant of the licence.
(5) Where a wholesale dealer has paid the full fee but his turnover for the first year of trading was lower than £40,000, if he sends a declaration certifying the actual lower turnover, the relevant authority shall refund the excess.
(6) For the purposes of this paragraph, “turnover” has the same meaning as in regulation 11 and “trading” means trading as a wholesale dealer.
Animal test certificatesU.K.
6. The fee for an Animal Test Certificate—Type A application is £305, and the fee for an Animal Test Certificate—Type B application is £735.U.K.
Marketing authorisations (parallel import)U.K.
7. The fee for an application for a marketing authorisation (parallel import) is £1,745.U.K.
Export CertificatesU.K.
8. The fee for an application for an export certificate is £25 and, for the supply of a certified copy of the original certificate, £10.U.K.
PART 3U.K.Fees Relating to Applications for Assistance in Connection with Mutual Recognition Applications
1.—(1) The fee for an application for assistance in connection with a mutual recognition application made no more than six months after the grant of the marketing authorisation to which it relates is as specified in the second column of the table below.U.K.
(2) Where subsequent applications of the type described in sub-paragraph (1) are made no more than six months of the grant of the marketing authorisation the fee payable shall be that specified in the third column of the table for the sixth and each additional Member State which was not covered by the previous applications.
| Type of application | Basic Fee (£) | Additional Fee for the sixth and each additional Member State (£) |
|---|---|---|
| Major | 3,995 | 865 |
| Complex | 2,670 | 420 |
| Standard | 1,150 | 215 |
| Simple | 390 | 70 |
2.—(1) The fee for an application for assistance in connection with a mutual recognition application made more than six months after the grant of the marketing authorisation to which it relates is as specified in the second column of the table below.U.K.
(2) Where subsequent applications of the type described in sub-paragraph (1) are made within six months of that application for assistance the fee payable shall be that specified in the third column of the table for the sixth and each additional Member State which was not covered by the previous applications.
| Type of application | Basic Fee (£) | Additional Fee for the sixth and each additional Member State (£) |
|---|---|---|
| Category I | 9,795 | 1,230 |
| Category II | 6,540 | 820 |
| Category III | 5,230 | 655 |
PART 4U.K.Fees Relating to Applications for the variation of Marketing Authorisations, Product Licences, Manufacturer’s Licences, Wholesale Dealer’s Licences and Animal Test Certificates
1. The application fee for a variation to a marketing authorisation of a type specified in the table below is that specified opposite it.U.K.
| Type of variation | Fee (£) | |
|---|---|---|
| 1 | Change following modification(s) to the manufacturing authorisation | 620 |
| 2 | Change in the name of the medicinal product (either invented name or common name) | 620 |
| 3 | Change in the name and/or address of the marketing authorisation holder | 240 |
| 4 | Replacement of an excipient with a comparable excipient (excluding adjuvants for vaccines and biologically derived excipients) | 620 |
| 5 | Change in the colouring system of the product (addition, deletion or replacement of colourant(s)) | 620 |
| 6 | Change in the flavouring system of the product (addition, deletion or replacement of flavour(s)) | 620 |
| 7 | Change in coating weight of tablets or change in weight of capsule shells | 620 |
| 8 | Change in the qualitative composition of immediate packaging material | 620 |
| 9 | Deletion of an indication | 620 |
| 10 | Deletion of a route of administration | 620 |
| 11 | Addition or replacement of measuring device for dosage forms | 620 |
| 12 | Change in the manufacturer(s) of active substance | 620 |
| 13 | Change in name of manufacturer of active substance | 240 |
| 14 | Change in supplier of intermediate compound used in the manufacture of the active substance | 620 |
| 15 | Minor change of manufacturing process of the active substance | 620 |
| 16 | Change in specification of starting material or intermediate used in the manufacture of the active substance | 620 |
| 17 | Change in batch size of active substance | 620 |
| 18 | Change in specification of active substance | 620 |
| 19 | Minor change in manufacture of the medicinal product | 620 |
| 20 | Change in in-process controls applied during the manufacture of the product | 620 |
| 21 | Change in the batch size of finished product | 620 |
| 22 | Change in specification of the medicinal product | 620 |
| 23 | Synthesis or recovery of non-pharmacopoeial excipients which had been described in the original dossier | 620 |
| 24 | Change in specification of excipients in the medicinal product (excluding adjuvants for vaccines) | 620 |
| 25 | Extension of shelf life as foreseen at time of authorisation | 620 |
| 26 | Extension of the shelf life or retest period of the active substance | 620 |
| 27 | Change in shelf life after first opening | 620 |
| 28 | Change in shelf life after reconstitution | 620 |
| 29 | Change in the storage conditions | 620 |
| 30 | Change in test procedure of active substance | 620 |
| 31 | Change in test procedure for a starting material or intermediate used in the manufacture of the active substance | 620 |
| 32 | Change in the test procedures of the medicinal product | 620 |
| 33 | Changes to comply with supplements to pharmacopoeias | 620 |
| 34 | Change in test procedures of non-pharmacopoeial excipients | 620 |
| 35 | Change in test procedure of immediate packaging | 620 |
| 36 | Change in test procedure of administrative device | 620 |
| 37 | Change in pack size for a medicinal product | 620 |
| 38 | Change in container shape | 620 |
| 39 | Change of imprints, bossing or other markings (except scoring) on tablets or printing on capsules, including addition or changes of inks used for product marking | 620 |
| 40 | Change of dimensions of tablets, capsules, suppositories or pessaries without change of quantitive composition and mean mass | 620 |
| 41 | Change in the manufacturing process of a non proteinaceous component due to the subsequent introduction of a biotechnology step | 620 |
2. The application fee for any other variation to a marketing authorisation (other than a mutually recognised marketing authorisation), or for any variation to a product licence, shall be £2,460 save as provided in the table below.U.K.
| Type of variation | Fee (£) | |
|---|---|---|
| 1 | Change made simultaneously as a change made to another product by the same marketing authorisation holder where the changes are identical and there is identical supporting data | 240 |
| 2 | Change of distributor where no other aspects of the dossier are changed and the marketing authorisation holder remains the same | 240 |
| 3 | Change of marketing authorisation holder where no other aspects of the dossier are changed | 240 |
| 4 | Simple dosage instruction changes where the change is not the result of safety concerns, no new studies are required to support the change and the dose in mg/kg body weight remains the same | 620 |
| 5 | Addition or change to user safety warnings where no other aspects of the dossier are changed, no user safety warnings are removed, no new studies are required to support the change and the proposed warnings serve to increase the protection of the user | 620 |
| 6 | Corrections or simple text layout changes to summary of product characteristics and/or product literature where the changes are not a result of safety concerns, no new studies are required to support the change and no other aspects of the dossier are changed | 620 |
| 7 | Any change to a licence relating solely to an emergency vaccine | 40 |
Mutually recognised marketing authorisationsU.K.
3.—(1) The fee for an application for the variation of a mutually recognised marketing authorisation shall, in respect of each individual variation to which the application relates, be that specified in the table below.U.K.
(2) In the table, “connected variation” means a variation to which sub-paragraph (1) applies made simultaneously or after a variation application for another such authorisation for which a fee is paid in pursuance of sub-paragraph (1), and where, for both applications the data relied upon and the applicant is the same.
| Mutually recognised marketing authorisation variation type | Fee—United Kingdom acting as the Reference Member State (£) | Fee—United Kingdom not acting as the Reference Member State (£) |
|---|---|---|
| Type IA notification | 1,590 | 240 |
| Type IB | 2,615 | 240 |
| Type II | 9,145 | 2,460 |
| Variation with extras | 10,460 | 4,375 |
| Connected variation | 1,590 | 240 |
Manufacturer’s licencesU.K.
4. The fee for an application for the variation of a manufacturer’s licence is £150 for each individual variation save that the fee is—U.K.
(a)£110 in respect of a licence to which paragraph 4(2) of Part 2 of this Schedule applies;
(b)£445 where scientific or pharmaceutical assessment is required.
Wholesale dealer’s licencesU.K.
5. The fee for an application for a variation of a wholesale dealer’s licence is £150 for each individual variation save that the fee is £445 where scientific or pharmaceutical assessment is required.U.K.
Animal test certificatesU.K.
6. The fee for an application for the variation of an animal test certificate is £240 in respect of each individual variation.U.K.
PART 5U.K.Fees Relating to Applications for the Renewal of Marketing Authorisations, Product Licences, Manufacturer’s Licences and Animal Test Certificates
Marketing authorisations and product licencesU.K.
1. The fee for an application to renew a marketing authorisation or product licence or the grant of such an authorisation or licence in circumstances to which regulation 7(1)(b) applies—U.K.
(a)for an emergency vaccine is £40;
(b)for a herbal product is £375; and
(c)in any other case is £1,110.
Manufacturer’s licencesU.K.
2. The fee for an application to renew a manufacturer’s licence only relating to products to which paragraph 4(2) of Part 2 of this Schedule applies is £110.U.K.
Animal test certificatesU.K.
3. The fee for an application to renew an animal test certificate is £115.U.K.
Article 26.3 marketing authorisationsU.K.
4. Where an Article 26.3 marketing authorisation is renewed, paragraph 1 does not apply in respect of the first renewal application, in which case no fee is payable.U.K.
S.I. 1971/1450.