Source: http://www.legislation.gov.uk/ukpga/1968/67/part/II/crossheading/licences-of-right
Timestamp: 2013-05-18 13:33:45
Document Index: 359937637

Matched Legal Cases: ['art. 3', 'art. 3', 'art. 7', 'art. 2', 'art. 2', 'art. 2', 'art. 2', 'art. 2', 'art. 2', 'art. 1', 'art. 2', 'art. 3', 'art. 3', 'art. 3']

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Changes to legislation:There are outstanding changes not yet made by the legislation.gov.uk editorial team to Medicines Act 1968. Any changes that have already been made by the team appear in the content and are referenced with annotations.Changes to LegislationRevised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.Changes and effects yet to be applied to the whole Act, associated Parts and Chapters:Changes and effectsThis section lists the changes and effects yet to be applied to the whole Act, associated Parts and Chapters where applicable. This includes any insertions of whole new Parts, Chapters or provisions yet to be inserted into this Act. These effects are included in this view as they may be (but won’t necessarily be) relevant to the specific provision that you are viewing.Act amendment to earlier affecting provision SI 1994/3144 reg. 10 Sch. 4 para. 10(b) by S.I. 2006/2407 Sch. 8 Pt. 2 para. 11(b)Act amendment to earlier affecting provision SI 1994/3144 reg. 10 Sch. 4 para. 9(b) by S.I. 2006/2407 Sch. 8 Pt. 2 para. 11(a)Act excluded by S.I. 2005/2745 Pt. 5 para. 44(1)(2)Act words substituted by 2005 c. 4 Sch. 11 para. 6Blanket amendment words substituted by S.I. 2011/1043 art. 3 6Whole provisions yet to be inserted into this Act (including any effects on those provisions):s. 2A inserted by S.I. 2005/1094 art. 3s. 2A-9 repealed by S.I. 2012/1916 Sch. 35s. 22 22A substituted for s. 20 by S.I. 2005/1094 Sch. 1 para. 3s. 22A applied by SI 1992/605 Sch. (as amended) by S.I. 2005/2754 Sch. 4 para. 6(a)s. 22A excluded by S.I. 2005/2754 Sch. 5 Pt. 1 para. 19(3)(a)(i)s. 22A(2)-(9) applied by SI 1978/1006 reg. 7(3) (as substituted) by S.I. 2005/2754 Sch. 4 para. 3(b)s. 22A(10)(b) applied by SI 1978/1006 reg. 7(3) (as substituted) by S.I. 2005/2754 Sch. 4 para. 3(b)s. 49B inserted by S.I. 2005/2789 Sch. 5 para. 7s. 72A 72B inserted by 2006 c. 28 s. 30(1)s. 72A(2) text amended by S.I. 2006/2407 Sch. 8 Pt. 1 para. 38(a)s. 72A(4)(b) text amended by S.I. 2006/2407 Sch. 8 Pt. 1 para. 38(b)s. 72A(5)(b) text amended by S.I. 2006/2407 Sch. 8 Pt. 1 para. 38(c)s. 72A(6) text amended by S.I. 2006/2407 Sch. 8 Pt. 1 para. 38(d)s. 72B(1) substituted by S.I. 2010/231 Sch. 4 para. 1(6)s. 72B(1) text amended by S.I. 2007/289 Sch. 1 para. 2(10)ss. 74A-74L inserted by S.I. 2010/231 Sch. 4 para. 1(8)s. 84A inserted by S.I. 2010/231 Sch. 4 para. 1(16)Sch. 1A para. 6(1) Sch. 1A para. 6 renumbered as Sch. 1A para. 6(1) by 2009 c. 21 Sch. 3 para. 1(2)Sch. 1A para. 6(2) inserted by 2009 c. 21 Sch. 3 para. 1(3)Sch. 1A inserted by S.I. 2005/1094 art. 7(2)Sch. 1A para. 5(2)(bb) inserted by S.I. 2005/2754 Sch. 1 para. 4(b)Sch. 1A repealed by S.I. 2012/1916 Sch. 35Sch. 1A para. 4(1)(b) text amended by S.I. 2005/2754 Sch. 1 para. 4(a)Commencement Orders yet to be applied to the Medicines Act 1968:Commencement OrdersThis section lists the commencement orders yet to be applied to the whole Act. These effects are included in this view as they may be (but won’t necessarily be) relevant to the specific provision that you are viewing. Where applicable the commencement orders are listed under two headings, firstly those that bring some part of the Act you are viewing into force and secondly, those that bring into force legislation that affects some part of the legislation you are viewing. If you are viewing a prospective version or there is a prospective version available there may be commencement orders listed here that are relevant to the provision you are viewing.Commencement Orders bringing legislation that affects this Act into force:S.I. 2005/3175 art. 2(2) commences (2004 c. 33)S.I. 2007/1179 art. 2 commences (1999 c. 8)S.I. 2007/1897 art. 2 commences (2005 c. 9)S.I. 2008/2714 art. 2 commences (2006 c. 28)S.I. 2009/1604 art. 2 commences (2005 c. 4)S.I. 2010/30 art. 2-4 commences (2009 c. 21)S.I. 2010/1621 art. 1 2 commences (S.I. 2010/231)S.I. 2012/1319 art. 2(4) commences (2012 c. 7) Licences of rightE+W+S+N.I.25 Entitlement to licence of right. E+W+S+N.I.(1)Where any of the provisions of subsections (2) to (5) of section 16 of this Act has effect in relation to a person, he may, before such date as may be appointed for the purposes of this section by an order made by the Ministers, make an application in accordance with section 18 of this Act, stating that it is an application for a licence of right.
(2)On any such application made as mentioned in the preceding subsection the applicant, on proving that any of the provisions of subsections (2) to (5) of section 16 of this Act has effect in relation to him, shall be entitled to the grant of a licence under this Part of this Act in accordance with the next following section.
(3)In this section and in sections 26 and 27 of this Act any reference to proof is a reference to proof to the reasonable satisfaction of the licensing authority.
(4)In this Act “licence of right” means a licence to which a person is entitled by virtue of this section, including such a licence which has been renewed (with or without modifications) but not a licence granted instead of the renewal of such a licence.
Annotations:Annotations are used to give authority for changes and other effects on the legislation you are viewing and to convey editorial information. They appear at the foot of the relevant provision or under the associated heading. Annotations are categorised by annotation type, such as F-notes for textual amendments and I-notes for commencement information (a full list can be found in the Editorial Practice Guide). Each annotation is identified by a sequential reference number. For F-notes, M-notes and X-notes, the number also appears in bold superscript at the relevant location in the text. All annotations contain links to the affecting legislation.Modifications etc. (not altering text)C1Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)26 Scope of licence of right in different cases. E+W+S+N.I.(1)Where a person is entitled to the grant of a licence of right by reason that subsection (2) or subsection (3) of section 16 of this Act has effect in relation to him, he shall be entitled to the grant of a product licence; but, subject to the following provisions of this section,—
(a)the licence shall be granted so as not to extend to medicinal products of any description other than those in respect of which the conditions specified in the subsection in question are proved to have been fulfilled, and
(b)where the conditions specified in subsection (3) (but not those specified in subsection (2)) of that section are proved to have been fulfilled, then, without prejudice to the preceding paragraph, the licence granted shall be limited to the importation of medicinal products.
(2)Where a person is entitled to the grant of a licence of right by reason that subsection (4) of section 16 of this Act has effect in relation to him, he shall be entitled to the grant of a manufacturer’s licence; but, subject to the following provisions of this section, the licence shall be granted so as not to extend—
(a)to medicinal products of any description, unless it is proved that medicinal products of that description were being manufactured or assembled in the course of the business in question during the period mentioned in that subsection, or
(b)to operations of any kind other than those in relation to which that subsection has been proved to have effect.
(3)Where a person is entitled to the grant of a licence of right by reason that subsection (5) of section 16 of this Act has effect in relation to him, he shall be entitled to the grant of a wholesale dealer’s licence.
(4)A licence of right granted in accordance with subsection (1) or subsection (2) of this section shall (without prejudice to either of those subsections) be granted subject to such provisions as appear to the licensing authority to be requisite for securing that the specification of medicinal products of any description to which the licence relates, and the purposes for which any such products are authorised by the licence to be sold, supplied, exported, imported, manufactured or assembled, will be in accordance with those stated in the application for the licence.
(5)Where a licence of right—
(a)is granted in accordance with subsection (1) or subsection (2) of this section in circumstances where, immediately before the first appointed day, the manufacture of medicinal products of any description to which the licence relates was authorised by a licence issued under Part I of the M1Therapeutic Substances Act 1956 or under Part II of the M2Diseases of Animals Act 1950 or of the M3Diseases of Animals Act (Northern Ireland) 1958, or
(b)is granted in accordance with subsection (1) of this section in circumstances where, immediately before the first appointed day, the importation of medicinal products of any such description was authorised by a licence so issued,
the provisions of the licence so issued, and the provisions of any regulations made under Part I of the M4Therapeutic Substances Act 1956 or (as the case may be) of any order made under Part II of the said Act of 1950 or of the said Act of 1958, in so far as immediately before that day they were applicable to medicinal products of that description, shall be deemed to be incorporated in the licence of right granted under this Act, in its application to medicinal products of that description, and shall have effect accordingly as provisions of the licence of right until it expires or is renewed.
(6)A breach of any requirement imposed by this section in respect of the grant of a licence shall not invalidate the licence; and, except as provided by section 107 of this Act, the duty of the licensing authority to comply with any such requirement shall not be enforceable by any legal proceedings.
Annotations:Annotations are used to give authority for changes and other effects on the legislation you are viewing and to convey editorial information. They appear at the foot of the relevant provision or under the associated heading. Annotations are categorised by annotation type, such as F-notes for textual amendments and I-notes for commencement information (a full list can be found in the Editorial Practice Guide). Each annotation is identified by a sequential reference number. For F-notes, M-notes and X-notes, the number also appears in bold superscript at the relevant location in the text. All annotations contain links to the affecting legislation.Modifications etc. (not altering text)C2Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)Marginal CitationsM11956 c. 25. M21950 c. 36. M31958 c. 13 (N.I.) M41956 c. 25. 27 Proceedings on application for licence of right. E+W+S+N.I.(1)Sections 19 to 22 of this Act shall not have effect in relation to any application for a licence of right.
(2)If on any such application the licensing authority—
(a)propose to refuse to grant a licence on that application, on the grounds that none of the provisions of subsections (2) to (5) of section 16 of this Act has been proved to have effect in relation to the applicant, or
(b)propose to grant a licence which will not extend to some of the matters specified in the application.
the licensing authority shall, before the end of the period of three months from the date on which the application is received by them, serve on the applicant a notice stating their proposals and the reasons for them and, in a case falling within paragraph (b) of this subsection, the matters specified in the application to which it is proposed that the licence should not extend.
(3)If, within the time allowed after the service of a notice under subsection (2) of this section, the applicant gives notice to the licensing authority of his desire to be heard under this subsection or makes representations in writing to the licensing authority with respect to their proposals, then, before determining the application, the licensing authority shall afford to him an opportunity of appearing before, and being heard by, a person appointed for the purpose by the licensing authority, or shall take those representations into account, as the case may be.
(4)Where the applicant avails himself of the opportunity afforded to him in pursuance of subsection (3) of this section or makes representations in writing as mentioned in that subsection, then if—
(a)the licensing authority refuse to grant a licence on the application, or
(b)grant a licence otherwise than in accordance with the application, and the applicant requests the licensing authority to state their reasons.
the licensing authority shall serve on the applicant a notice stating the reasons for their decision.
(5)If, in a case where the licensing authority have served a notice under subsection (2) of this section, the application is not finally disposed of before the date which, in relation to any matters specified in the application, is the relevant date, then on and after that date, and until the application has been finally disposed of, the provisions of this Act shall have effect in relation to those matters as if the licensing authority had granted a licence of right in accordance with the application.
(6)Where, on an application for a licence of right, the licensing authority do not serve a notice under subsection (2) of this section before the end of the period mentioned in that subsection, the licensing authority shall be required to grant a licence in accordance with sections 25 and 26 of this Act as if all the matters specified in the application had been proved; and if such a licence has not been granted before the date which, in relation to any of those matters, is the relevant date, the provisions of this Act shall have effect on and after that date in relation to those matters as if the licensing authority had granted a licence of right in accordance with the application.
(7)For the purposes of this section the relevant date, in relation to any matters specified in an application, is the date on which, in accordance with one or more orders made under section 17 of this Act, that subsection of section 16 of this Act which has effect in relation to those matters ceases to have effect in relation to them; and an application shall for the purposes of this section be taken to be finally disposed of on (but not before) the occurrence of whichever of the following events last occurs, that is to say—
(a)the licensing authority make a decision determining the application;
(b)the time within which an application under section 107 of this Act with respect to that decision can be made expires without its having been made;
(c)if such an application under section 107 of this Act is made, the proceedings on the application under that section are finally determined or abandoned or otherwise disposed of;
(d)if there is an appeal against the decision in any such proceedings as are mentioned in paragraph (c) of this subsection, or an appeal against the decision on such an appeal, the proceedings on that appeal are finally determined or abandoned or otherwise disposed of;
(e)the time for bringing any such appeal as is mentioned in paragraph (d) of this subsection expires without its having been brought.
(8)Subsection (7) of section 21 of this Act shall have effect in relation to a person appointed under subsection (3) of this section as it has effect in relation to a person appointed under subsection (5) of that section.
Annotations:Annotations are used to give authority for changes and other effects on the legislation you are viewing and to convey editorial information. They appear at the foot of the relevant provision or under the associated heading. Annotations are categorised by annotation type, such as F-notes for textual amendments and I-notes for commencement information (a full list can be found in the Editorial Practice Guide). Each annotation is identified by a sequential reference number. For F-notes, M-notes and X-notes, the number also appears in bold superscript at the relevant location in the text. All annotations contain links to the affecting legislation.Modifications etc. (not altering text)C3Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)C4Power to exclude s. 27(5)(6) conferred by Medicines Act 1971 (c. 69), s. 1(2)(a)Previous: CrossheadingNext: CrossheadingBack to topOptions/HelpPrint OptionsPrint The Whole ActPDF The Whole ActWeb page The Whole ActPrint The Whole PartPDF The Whole PartWeb page The Whole PartPrint This Cross Heading onlyPDF This Cross Heading onlyWeb page This Cross Heading onlyYou have chosen to open The Whole ActThe Whole Act you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.Would you like to continue?Continue to openYou have chosen to open The Whole Act as a PDFThe Whole Act you have selected contains over 200 provisions and might take some time to download.Would you like to continue?Continue to openYou have chosen to open the Whole ActThe Whole Act you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.Would you like to continue?Continue to openLegislation is available in different versions:Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.Original (As Enacted or Made):The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.See additional information alongside the contentGeographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.Opening OptionsDifferent options to open legislation in order to view more content on screen at onceMore ResourcesAccess essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:the original print PDF of the as enacted version that was used for the print copylists of changes made by and/or affecting this legislation itemconfers power and blanket amendment detailsall formats of all associated documentscorrection slipslinks to related legislation and further information resourcesMore ResourcesUse this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:the original print PDF of the as enacted version that was used for the print copycorrection slipsClick 'View More' or select 'More Resources' tab for additional information including:lists of changes made by and/or affecting this legislation itemconfers power and blanket amendment detailsall formats of all associated documentslinks to related legislation and further information resources© Crown copyrightYou may use and re-use the information featured on this website (not including logos) free of charge in any format or medium, under the terms of the Open Government Licence