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- Original (As made)
This is the original version (as it was originally made).
Regulation 2(2)(a)
Text | Amendment | |
---|---|---|
1. | In the definition of “assistance in connection with a mutual recognition application” | (a)for “the second paragraph of Article 17.3 of the Directive 81/851/EEC” substitute:
(b)for “specified in Articles 18.2 and 18.3” substitute:
|
2. | After “Directive 92/74” | Add the following new definition: ““Directive 2001/82/EC” means Directive 2001/82/EC of 6th November 2001 on the Community code relating to veterinary medicinal products;” |
3. | To the definition of “EEA Agreement” | for “as amended by the Decision of the EEA Joint Committee No 7/94;” substitute:
|
4. | After the definition of “EEA State” | Add the following new definition: ““export certificate” means a certificate issued under section 50 of the Act;” |
5. | After the definition of “the Ministers” | Add the following new definition: ““mutually recognised marketing authorisation” means a marketing authorisation which has a mutual recognition from a member State;” |
6. | After the definition of “Regulation (EC) No 541/95” | Add the following new definition: ““Regulation (EC) No 1084/2003” means Commission Regulation (EC) No 1084/2003 of 3rd June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State;” |
7. | After the definition of “relevant authority” | add the following new definitions: ““specific batch control” means consideration by the licensing authority of a marketing authorisation or animal test certificate holder’s documentation relating to a specific batch of a veterinary medicinal product (other than an immunological product) where the quality characteristics of that batch, or of a starting material used during its manufacture, differ from those detailed in the marketing authorisation or animal test certificate, so that the licensing authority may, prior to the release of the batch in question onto the market, form a view as to whether action under the 1994 Regulations would be required either to instigate a recall or to prohibit the supply of the veterinary medicinal product should the batch be placed on the market; “starting material” means in relation to specific batch control a material required to produce the finished veterinary medicinal product for sale, and includes the finished product’s container and packaging;” |
8. | In the definition of “variation with extras” | after “falling within Annex II to Regulation (EC) No 541/95” add:
|
9. | In the definition of “Veterinary Medicinal Product” | for “Directive 81/851/EEC” substitute “Directive 2001/82/EC” |
Regulation 3(2)
Text | Amendment | |
---|---|---|
1. | In the definition of “abridged standard application” | for “Article 5.10 of Directive 81/851/EEC;” substitute “Article 13.1 of Directive 2001/82/EC;” |
2. | After the definition of “active ingredient” | add the following new definitions: ““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— (a) 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; (b) a pharmaceutical veterinary medicinal product which has been authorised in a member State for use with food-producing species on whom 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 (c) 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”;”. |
3. | In the definition of “Article 15.2 marketing authorisation” | for “of the type specified in Article 15.2 of Directive 81/851/EEC” substitute:
|
4. | In the definition of “immunological Veterinary Medicinal Product” | for “Directive 90/677/EEC”, substitute “Directive 2001/82/EC” |
5. | In the definition of “individual variation” | in sub-paragraph (a) for “Regulation (EC) No 541/95” substitute “Regulation (EC) No 1084/2003” |
6. | At “mutually recognised marketing authorisation” | delete the definition |
7. | In the definition of “Reference Member State” | for “Article 2.2 of Regulation (EC) No 541/95;” substitute:
|
8. | After the definition of “standard application” | for the remaining text, substitute the following definitions: ““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 “1A” is entered in the final column of that Table; “Type IB variation” 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 “1B” is entered in the final column of that Table; “Type II variation” means a variation of a mutually recognised marketing authorisation of the type referred to in Article 3.3 of Regulation (EC) No 1084/2003.” |
Regulation 3(2)(c)
Column (1) | Column (2) | Column (3) | ||
---|---|---|---|---|
Kind of application | Fee—United Kingdom acting as the Reference Member State | Fee—United Kingdom not acting as the Reference Member State | ||
Mutually recognised marketing authorisation variation type | Old fee (where applicable) £ | New fee £ | Old fee (where applicable) £ | New fee £ |
Type IA Notification | — | 1,515 | — | 230 |
Type IB Variation | — | 2,490 | — | 230 |
Type II Variation | 8,455 | 8,710 | 2,275 | 2,345 |
Variation with extras | 9,670 | 9,960 | 4,045 | 4,165 |
Regulation 3(7)
Column (1) | Column (2) | Column (3) | Column (4) |
---|---|---|---|
Provision of the Medicines (Products for Animal Use—Fees) Regulations 1998 | Subject matter | Old fee £ | New fee £ |
SCHEDULE 1, PART II | Fees relating to applications for the grant of marketing authorisations, product licences, manufacturer’s licences, wholesale dealer’s licences and animal test certificates | ||
Paragraph 1 | Marketing authorisations and product licences— | ||
Paragraph 1, Table A, column (2) | Fee for an application for a type A marketing authorisation— | ||
| Major application | 20,590 | 21,210 |
| Complex application | 11,945 | 12,305 |
| Standard application | 5,160 | 5,315 |
| Abridged standard application | 4,030 | 4,150 |
| Simple application | 1,435 | 1,480 |
Paragraph 1 Table A, column (3) | Fee for an application for a type B marketing authorisation— | ||
| Major application | 11,360 | 11,700 |
| Complex application | 6,820 | 7,025 |
| Standard application | 3,410 | 3,515 |
| Simple application | 905 | 930 |
Paragraph 1, Table A, column (4) | Fee for an application for a product Licence— | ||
| Major application | 20,590 | 21,210 |
| Complex application | 11,945 | 12,305 |
| Standard application | 5,160 | 5,315 |
| Simple application | 1,435 | 1,480 |
Paragraph 2, Table B, column (2) | Fee for an application for an Article 26.3 marketing authorisation— | ||
| Major application | 11,945 | 12,305 |
| Complex application | 5,160 | 5,315 |
Paragraph 3 | Application for a marketing authorisation by holder of Article 26.3 marketing authorisation— | ||
Paragraph 3(a) | Major application previously made | 8,645 | 8,905 |
Paragraph 3(b) | Complex application previously made | 6,785 | 6,990 |
Paragraph 6 | Manufacturer’s licences— | ||
Paragraph 6(1)(a) | application for manufacturer’s licence in respect of products whose sale or supply does not require a marketing authorisation or product licence, etc, or emergency vaccines | 100 | 105 |
Paragraph 6(1)(b) | Other cases | 2,315 | 2,385 |
Paragraph 7 | Wholesale dealer’s licences— | ||
Paragraph 7(1) | Application fee where anticipated turnover £40,000 or more | 1,345 | 1,385 |
Paragraph 7(2) | Application fee where anticipated turnover less than £40,000 | 550 | 565 |
Paragraph 9 | Marketing authorisation (parallel import) | 1,610 | 1,660 |
SCHEDULE I, PART III | Fees relating to applications for assistance in connection with mutual recognition applications | ||
Paragraph 4, Table C, column (2) | Basic fee— | ||
| Major | 3,695 | 3,805 |
| Complex | 2,470 | 2,545 |
| Standard | 1,065 | 1,095 |
| Simple | 360 | 370 |
Paragraph 4, Table C, column (3) | Additional fee for the sixth and each additional member State— | ||
| Major | 800 | 825 |
| Complex | 390 | 400 |
| Standard | 200 | 205 |
Paragraph 5, Table D, column (2) | Basic fee | ||
| Category I application | 9,060 | 9,330 |
| Category II application | 6,050 | 6,230 |
| Category III application | 4,835 | 4,980 |
Paragraph 5, Table D, column (3) | Additional fee for the sixth and each additional member State— | ||
| Category I application | 1,135 | 1,170 |
| Category II application | 760 | 780 |
| Category III application | 605 | 625 |
SCHEDULE 1, PART IV | Fees relating to applications for the variation of marketing authorisations, product licences, manufacturer’s licences, wholesale dealer’s licences and animal test certificates | ||
Paragraph 1 | Application for a minor variation to a marketing authorisation (other than a mutually recognised marketing authorisation)— | ||
| Change in the content of the manufacturing authorisation | 575 | 590 |
| Change in the name of the medicinal product (either invented name or common) | 575 | 590 |
| Change in the name and/or address of the marketing authorisation holder | 225 | 230 |
| Replacement of an excipient with a comparable excipient (excluding adjuvants for vaccines and biologically derived excipients) | 575 | 590 |
| Addition, deletion or replacement of a colorant | 575 | 590 |
| Addition, deletion or replacement of a flavour | 575 | 590 |
| Change in coating weight of tablets or change in weight of capsule shells | 575 | 590 |
| Change in the qualitative composition of immediate packaging material | 575 | 590 |
| Deletion of an indication | 575 | 590 |
| Deletion of a route of administration | 575 | 590 |
| Addition or replacement of measuring device | 575 | 590 |
| Change in the manufacturer(s) of active substance. | 575 | 590 |
| Change in name of manufacturer of active substance | 225 | 230 |
| Change in supplier of intermediate compound used in the manufacture | 575 | 590 |
| Minor change of manufacturing process of the active substance. | 575 | 590 |
| Change in specification of starting material or intermediate used in the manufacture of the active substance | 575 | 590 |
| Batch size of active substance. | 575 | 590 |
| Change in specification of active substance | 575 | 590 |
| Minor change in manufacture of the medicinal product | 575 | 590 |
| Change in in-process controls applied during the manufacture of the product | 575 | 590 |
| Change in the batch size of finished product | 575 | 590 |
| Change in specification of the medicinal product | 575 | 590 |
| Synthesis or recovery of non-pharmacopoeial excipients which had been described in the original dossier | 575 | 590 |
| Change in specification of excipients in the medicinal product (excluding adjuvants for vaccines) | 575 | 590 |
| Extension of shelf life as foreseen at time of authorisation | 575 | 590 |
| Extension of the shelf life or retest period of the active substance | 575 | 590 |
| Change in shelf life after first opening | 575 | 590 |
| Change in shelf life after reconstitution | 575 | 590 |
| Change in the storage conditions | 575 | 590 |
| Change in test procedure of active substance | 575 | 590 |
| Change in the test procedure for a starting material or intermediate used in the manufacture of the active substance | 575 | 590 |
| Change in the test procedures of the medicinal product | 575 | 590 |
| Changes to comply with supplements to pharmacopoeias | 575 | 590 |
| Change in test procedures of non-pharmacopoeial excipients | 575 | 590 |
| Change in test procedure of immediate packaging | 575 | 590 |
| Change in test procedure of administration device | 575 | 590 |
| Change in pack size for a medicinal product | 575 | 590 |
| Change in container shape | 575 | 590 |
| 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 | 575 | 590 |
| Change of dimensions of tablets, capsules, suppositories or pessaries without change of quantitative composition and mean mass | 575 | 590 |
| Change in the manufacturing process of a non protinaceous component due to the subsequent introduction of a biotechnology step | 575 | 590 |
Paragraph 2 | Application fee for any other variation to a marketing authorisation (other than a mutually recognised marketing authorisation) other than the following specified cases | 2,275 | 2,345 |
| Change which is made where there is identical supporting data relating to another product which is also being changed, all the products are from the same marketing authorisation holder and the change is identical to the first change and is made at the same time | 225 | 230 |
| Change of distributor where no other aspects of the dossier are changed and the marketing authorisation holder remains the same | 225 | 230 |
| Change of marketing authorisation holder where no other aspects of the dossier are changed | 225 | 230 |
| 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 rate in mg/kg body weight remains the same | 575 | 590 |
| 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 | 575 | 590 |
| Corrections or simple text lay out changes to summary of product characteristics and/or product literature where the changes are not a result of safety, no new studies are required to support the change and no other aspects of the dossier are changed | 575 | 590 |
Paragraph 5 | Manufacturer’s licences— | ||
Paragraph 5(a) | Variations covered by Part II, paragraph 6(2) | 100 | 105 |
Paragraph 5(b) | Variation in any other case— | ||
Paragraph 5(b)(i) | Variation requiring assessment | 410 | 425 |
Paragraph 5(b)(ii) | Variation not requiring assessment | 140 | 145 |
Paragraph 6 | Wholesale dealer’s licences | ||
Paragraph 6(a) | Variation requiring assessment | 410 | 425 |
Paragraph 6(b) | Variation not requiring assessment | 140 | 145 |
Paragraph 7 | Variation of animal test certificate | 225 | 230 |
SCHEDULE 1, PART V | Fees relating to applications for the renewal of marketing authorisations, product licences, manufacturer’s licences and animal test certificates | ||
Paragraph 1 | Marketing authorisations and product licences— | ||
Paragraph 1(b) | Renewal of a marketing authorisation relating to a herbal product | 345 | 355 |
Paragraph 1(c) | Renewal in other cases | 1,025 | 1,055 |
Paragraph 2 | Renewal of Manufacturer’s licence | 105 | 110 |
Paragraph 3 | Renewal of Animal test certificate | 105 | 110 |
SCHEDULE 2 | Fees relating to site inspections | ||
Paragraph 2(1), Table A, column (2) | |||
| Supersite inspection | 9,525 | 9,810 |
| Major inspection | 5,010 | 5,160 |
| Standard inspection | 3,590 | 3,700 |
| Minor inspection | 1,935 | 1,995 |
Paragraph 2(2), Table B, column (2) | |||
| Supersite inspection | 15,795 | 16,270 |
| Major inspection | 8,730 | 8,990 |
| Standard inspection covering immunological Veterinary Medicinal Products | 5,695 | 5,865 |
| Other standard inspection | 4,290 | 4,420 |
| Minor inspection covering immunological Veterinary Medicinal Products | 2,870 | 2,955 |
| Other minor inspection | 2,870 | 2,955 |
Paragraph 2(3), Table C, column (2) | |||
| Supersite inspection | 6,920 | 7,130 |
| Major inspection | 4,675 | 4,815 |
| Standard inspection | 2,290 | 2,360 |
| Minor inspection | 1,185 | 1,220 |
Paragraph 2(4)(a) | Inspection of site limited solely to manufacture or assembly of products whose sale or supply does not require a marketing authorisation or product licence, etc | 100 | 105 |
Paragraph 3(1) | Inspection of either or both of premises and procedures for quality control of a biological product which is not a dormant product | 1,370 | 1,410 |
Paragraph 3(2) | Inspection in connection with an authorised or licensed biological product (other than a dormant biological product) granted a marketing authorisation etc because it was identical to an existing product | 55 | 60 |
SCHEDULE 5, PART II | Fees relating to applications for registration of homoeopathic veterinary medicinal products | ||
Paragraph 1, Table, Column (2) | Fees for applications in respect of products prepared from not more than 5 homoeopathic stocks— | ||
| Product both prepared solely from repeat stock and being of repeat formulation | 120 | 125 |
| Product which is either prepared solely from repeat stock or is of a repeat formulation | 345 | 355 |
| Any other application | 575 | 590 |
Paragraph 1, Table, column (3) | Fees for applications in respect of products prepared from more than 5 homoeopathic stocks— | ||
| Product both prepared solely from repeat stock and being of repeat formulation | 280 | 290 |
| Product which is either prepared solely from repeat stock or is of a repeat formulation | 505 | 520 |
| Any other application | 740 | 760 |
Paragraph 2 | Equivalent product registered under Part II of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 or in an EEA State— | ||
Paragraph 2(i) | Product prepared from not more than 5 homoeopathic stocks | 120 | 125 |
Paragraph 2(ii) | Product prepared from more than 5 homoeopathic stocks | 280 | 290 |
SCHEDULE 6 | Marketing authorisations, product licences, and animal test certificates: fees for references to the Veterinary Products Committee or to the Medicines Commission | ||
Paragraph 1, Table, column (2) | |||
| Major application | 1,620 | 1,670 |
| Complex application | 930 | 960 |
| Standard application | 430 | 445 |
| Simple application | 165 | 170 |
Paragraph 2 | Animal test certificate | 565 | 580 |
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