{ "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994", "json_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994.json", "id": "uksi/1994/3144", "title": "The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994", "short_title": "Medicines for Human Use (Marketing Authorisations Etc.) 1994", "long_title": "These Regulations implement for the United Kingdom, and in so far as they are concerned with medicinal products for human use, the Council Directives mentioned in regulation 1(2) in the definition of “relevant Community provisions”. They also contain provisions supplementing the provisions of Council Regulation (EEC) No. 2309/93. Both the Directives and the Regulation are concerned with the marketing of medicinal products.", "citation": "S.I. 1994/3144", "type": "uksi", "year": "1994", "number": "3144", "version": "current", "date": "1994-12-08", "revised": false, "valid_from": null, "extent": null, "unapplied_effects": 188, "provisions": [ { "path": "introduction", "kind": "introduction", "number": null, "heading": "Introductory text", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/introduction", "extent": null, "status": null, "parent": null }, { "path": "regulation/1", "kind": "regulation", "number": "1", "heading": "Citation, commencement and interpretation", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/regulation-1", "extent": null, "status": null, "parent": null }, { "path": "regulation/2", "kind": "regulation", "number": "2", "heading": "Responsibility for Member States' functions under the Regulations and Directives", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/regulation-2", "extent": null, "status": null, "parent": null }, { "path": "regulation/3", "kind": "regulation", "number": "3", "heading": "Marketing authorizations for relevant medicinal products", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/regulation-3", "extent": null, "status": null, "parent": null }, { "path": "regulation/4", "kind": "regulation", "number": "4", "heading": "Applications for the grant, renewal or variation of a United Kingdom marketing authorization", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/regulation-4", "extent": null, "status": null, "parent": null }, { "path": "regulation/5", "kind": "regulation", "number": "5", "heading": "Consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorization.", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/regulation-5", "extent": null, "status": null, "parent": null }, { "path": "regulation/6", "kind": "regulation", "number": "6", "heading": "Revocation, suspension or variation of a United Kingdom marketing authorization or the suspension of the use or marketing of medicinal products.", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/regulation-6", "extent": null, "status": null, "parent": null }, { "path": "regulation/7", "kind": "regulation", "number": "7", "heading": "Obligations of holders of marketing authorizations, and offences by holders of marketing authorizations and other persons", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/regulation-7", "extent": null, "status": null, "parent": null }, { "path": "regulation/8", "kind": "regulation", "number": "8", "heading": "Control of retail sale of supply of relevant medicinal products", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/regulation-8", "extent": null, "status": null, "parent": null }, { "path": "regulation/9", "kind": "regulation", "number": "9", "heading": "Consequential and other amendments of the Act and the Medicines Act 1971", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/regulation-9", "extent": null, "status": null, "parent": null }, { "path": "regulation/10", "kind": "regulation", "number": "10", "heading": "Application of enforcement provisions of the Act", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/regulation-10", "extent": null, "status": null, "parent": null }, { "path": "regulation/11", "kind": "regulation", "number": "11", "heading": "Other Schedules to have effect", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/regulation-11", "extent": null, "status": null, "parent": null }, { "path": "signature", "kind": "signature", "number": null, "heading": "Signature", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/signature", "extent": null, "status": null, "parent": null }, { "path": "schedule/1", "kind": "schedule", "number": "1", "heading": "EXEMPTIONS AND EXCEPTIONS FROM THE PROVISIONS OF REGULATION 3", "url": null, "extent": null, "status": null, "parent": null }, { "path": "schedule/1/paragraph/1", "kind": "paragraph", "number": "1", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-1/paragraph-1", "extent": null, "status": null, "parent": "schedule/1" }, { "path": "schedule/1/paragraph/2", "kind": "paragraph", "number": "2", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-1/paragraph-2", "extent": null, "status": null, "parent": "schedule/1" }, { "path": "schedule/1/paragraph/3", "kind": "paragraph", "number": "3", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-1/paragraph-3", "extent": null, "status": null, "parent": "schedule/1" }, { "path": "schedule/1/paragraph/4", "kind": "paragraph", "number": "4", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-1/paragraph-4", "extent": null, "status": null, "parent": "schedule/1" }, { "path": "schedule/1/paragraph/5", "kind": "paragraph", "number": "5", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-1/paragraph-5", "extent": null, "status": null, "parent": "schedule/1" }, { "path": "schedule/1/paragraph/6", "kind": "paragraph", "number": "6", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-1/paragraph-6", "extent": null, "status": null, "parent": "schedule/1" }, { "path": "schedule/1/paragraph/7", "kind": "paragraph", "number": "7", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-1/paragraph-7", "extent": null, "status": null, "parent": "schedule/1" }, { "path": "schedule/2", "kind": "schedule", "number": "2", "heading": "PROCEDURAL PROVISIONS RELATING TO THE GRANT, REVOCATION AND SUSPENSION OF UNITED KINGDOM MARKETING AUTHORIZATIONS", "url": null, "extent": null, "status": null, "parent": null }, { "path": "schedule/2/paragraph/1", "kind": "paragraph", "number": "1", "heading": "Interpretation", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-1", "extent": null, "status": null, "parent": "schedule/2" }, { "path": "schedule/2/paragraph/2", "kind": "paragraph", "number": "2", "heading": "Scope and application of the procedural provisions", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-2", "extent": null, "status": null, "parent": "schedule/2" }, { "path": "schedule/2/paragraph/3", "kind": "paragraph", "number": "3", "heading": "Scope and application of the procedural provisions", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-3", "extent": null, "status": null, "parent": "schedule/2" }, { "path": "schedule/2/paragraph/4", "kind": "paragraph", "number": "4", "heading": "Scope and application of the procedural provisions", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-4", "extent": null, "status": null, "parent": "schedule/2" }, { "path": "schedule/2/paragraph/5", "kind": "paragraph", "number": "5", "heading": "Requirement to consult the appropriate committee or the Medicines Commission", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-5", "extent": null, "status": null, "parent": "schedule/2" }, { "path": "schedule/2/paragraph/6", "kind": "paragraph", "number": "6", "heading": "Provisional opinion against authorization", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-6", "extent": null, "status": null, "parent": "schedule/2" }, { "path": "schedule/2/paragraph/7", "kind": "paragraph", "number": "7", "heading": "Licensing Authority’s decision", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-7", "extent": null, "status": null, "parent": "schedule/2" }, { "path": "schedule/2/paragraph/8", "kind": "paragraph", "number": "8", "heading": "Confirmation or alteration of the decision after taking into account the advice of the Medicines Commission", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-8", "extent": null, "status": null, "parent": "schedule/2" }, { "path": "schedule/2/paragraph/9", "kind": "paragraph", "number": "9", "heading": "Person appointed to hear representations", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-9", "extent": null, "status": null, "parent": "schedule/2" }, { "path": "schedule/2/paragraph/10", "kind": "paragraph", "number": "10", "heading": "Person appointed to hear representations", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-10", "extent": null, "status": null, "parent": "schedule/2" }, { "path": "schedule/2/paragraph/11", "kind": "paragraph", "number": "11", "heading": "Right to be heard by a person appointed or to make further representations", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-11", "extent": null, "status": null, "parent": "schedule/2" }, { "path": "schedule/2/paragraph/12", "kind": "paragraph", "number": "12", "heading": "Right to be heard by a person appointed or to make further representations", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-12", "extent": null, "status": null, "parent": "schedule/2" }, { "path": "schedule/2/paragraph/13", "kind": "paragraph", "number": "13", "heading": "Cases where suspension is to have immediate effect", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-13", "extent": null, "status": null, "parent": "schedule/2" }, { "path": "schedule/2/paragraph/14", "kind": "paragraph", "number": "14", "heading": "Cases where suspension is to have immediate effect", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-14", "extent": null, "status": null, "parent": "schedule/2" }, { "path": "schedule/3", "kind": "schedule", "number": "3", "heading": "OFFENCES, PENALTIES ETC.", "url": null, "extent": null, "status": null, "parent": null }, { "path": "schedule/3/paragraph/1", "kind": "paragraph", "number": "1", "heading": "Offences", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-1", "extent": null, "status": null, "parent": "schedule/3" }, { "path": "schedule/3/paragraph/2", "kind": "paragraph", "number": "2", "heading": "Offences", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-2", "extent": null, "status": null, "parent": "schedule/3" }, { "path": "schedule/3/paragraph/3", "kind": "paragraph", "number": "3", "heading": "Offences", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-3", "extent": null, "status": null, "parent": "schedule/3" }, { "path": "schedule/3/paragraph/4", "kind": "paragraph", "number": "4", "heading": "Offences", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-4", "extent": null, "status": null, "parent": "schedule/3" }, { "path": "schedule/3/paragraph/5", "kind": "paragraph", "number": "5", "heading": "Offences", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-5", "extent": null, "status": null, "parent": "schedule/3" }, { "path": "schedule/3/paragraph/6", "kind": "paragraph", "number": "6", "heading": "Offences", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-6", "extent": null, "status": null, "parent": "schedule/3" }, { "path": "schedule/3/paragraph/7", "kind": "paragraph", "number": "7", "heading": "Offences", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-7", "extent": null, "status": null, "parent": "schedule/3" }, { "path": "schedule/3/paragraph/8", "kind": "paragraph", "number": "8", "heading": "Offences", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-8", "extent": null, "status": null, "parent": "schedule/3" }, { "path": "schedule/3/paragraph/9", "kind": "paragraph", "number": "9", "heading": "Offences", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-9", "extent": null, "status": null, "parent": "schedule/3" }, { "path": "schedule/3/paragraph/10", "kind": "paragraph", "number": "10", "heading": "Offences", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-10", "extent": null, "status": null, "parent": "schedule/3" }, { "path": "schedule/3/paragraph/11", "kind": "paragraph", "number": "11", "heading": "Offences", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-11", "extent": null, "status": null, "parent": "schedule/3" }, { "path": "schedule/3/paragraph/12", "kind": "paragraph", "number": "12", "heading": "Offences", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-12", "extent": null, "status": null, "parent": "schedule/3" }, { "path": "schedule/3/paragraph/13", "kind": "paragraph", "number": "13", "heading": "Offences", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-13", "extent": null, "status": null, "parent": "schedule/3" }, { "path": "schedule/3/paragraph/14", "kind": "paragraph", "number": "14", "heading": "Penalties", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-14", "extent": null, "status": null, "parent": "schedule/3" }, { "path": "schedule/3/paragraph/15", "kind": "paragraph", "number": "15", "heading": "Miscellaneous", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-15", "extent": null, "status": null, "parent": "schedule/3" }, { "path": "schedule/3/paragraph/16", "kind": "paragraph", "number": "16", "heading": "Miscellaneous", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-16", "extent": null, "status": null, "parent": "schedule/3" }, { "path": "schedule/4", "kind": "schedule", "number": "4", "heading": "MODIFICATIONS OF ENFORCEMENT PROVISIONS OF THE ACT", "url": null, "extent": null, "status": null, "parent": null }, { "path": "schedule/4/paragraph/1", "kind": "paragraph", "number": "1", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-4/paragraph-1", "extent": null, "status": null, "parent": "schedule/4" }, { "path": "schedule/4/paragraph/2", "kind": "paragraph", "number": "2", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-4/paragraph-2", "extent": null, "status": null, "parent": "schedule/4" }, { "path": "schedule/4/paragraph/3", "kind": "paragraph", "number": "3", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-4/paragraph-3", "extent": null, "status": null, "parent": "schedule/4" }, { "path": "schedule/4/paragraph/4", "kind": "paragraph", "number": "4", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-4/paragraph-4", "extent": null, "status": null, "parent": "schedule/4" }, { "path": "schedule/4/paragraph/5", "kind": "paragraph", "number": "5", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-4/paragraph-5", "extent": null, "status": null, "parent": "schedule/4" }, { "path": "schedule/4/paragraph/6", "kind": "paragraph", "number": "6", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-4/paragraph-6", "extent": null, "status": null, "parent": "schedule/4" }, { "path": "schedule/4/paragraph/7", "kind": "paragraph", "number": "7", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-4/paragraph-7", "extent": null, "status": null, "parent": "schedule/4" }, { "path": "schedule/4/paragraph/8", "kind": "paragraph", "number": "8", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-4/paragraph-8", "extent": null, "status": null, "parent": "schedule/4" }, { "path": "schedule/4/paragraph/9", "kind": "paragraph", "number": "9", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-4/paragraph-9", "extent": null, "status": null, "parent": "schedule/4" }, { "path": "schedule/4/paragraph/10", "kind": "paragraph", "number": "10", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-4/paragraph-10", "extent": null, "status": null, "parent": "schedule/4" }, { "path": "schedule/4/paragraph/11", "kind": "paragraph", "number": "11", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-4/paragraph-11", "extent": null, "status": null, "parent": "schedule/4" }, { "path": "schedule/4/paragraph/12", "kind": "paragraph", "number": "12", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-4/paragraph-12", "extent": null, "status": null, "parent": "schedule/4" }, { "path": "schedule/4/paragraph/13", "kind": "paragraph", "number": "13", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-4/paragraph-13", "extent": null, "status": null, "parent": "schedule/4" }, { "path": "schedule/4/paragraph/14", "kind": "paragraph", "number": "14", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-4/paragraph-14", "extent": null, "status": null, "parent": "schedule/4" }, { "path": "schedule/5", "kind": "schedule", "number": "5", "heading": "LABELS", "url": null, "extent": null, "status": null, "parent": null }, { "path": "schedule/5/paragraph/1", "kind": "paragraph", "number": "1", "heading": "Interpretation", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-5/paragraph-1", "extent": null, "status": null, "parent": "schedule/5" }, { "path": "schedule/5/paragraph/2", "kind": "paragraph", "number": "2", "heading": "Introductory", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-5/paragraph-2", "extent": null, "status": null, "parent": "schedule/5" }, { "path": "schedule/5/paragraph/3", "kind": "paragraph", "number": "3", "heading": "Dispensed relevant medicinal products", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-5/paragraph-3", "extent": null, "status": null, "parent": "schedule/5" }, { "path": "schedule/5/paragraph/4", "kind": "paragraph", "number": "4", "heading": "Delivery and storage", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-5/paragraph-4", "extent": null, "status": null, "parent": "schedule/5" }, { "path": "schedule/5/paragraph/5", "kind": "paragraph", "number": "5", "heading": "Relevant medicinal products on a general sale list", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-5/paragraph-5", "extent": null, "status": null, "parent": "schedule/5" }, { "path": "schedule/5/paragraph/6", "kind": "paragraph", "number": "6", "heading": "Relevant medicinal products not on a general sale list", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-5/paragraph-6", "extent": null, "status": null, "parent": "schedule/5" }, { "path": "schedule/5/paragraph/7", "kind": "paragraph", "number": "7", "heading": "Prescription only relevant medicinal products", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-5/paragraph-7", "extent": null, "status": null, "parent": "schedule/5" }, { "path": "schedule/5/paragraph/8", "kind": "paragraph", "number": "8", "heading": "Exemptions", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-5/paragraph-8", "extent": null, "status": null, "parent": "schedule/5" }, { "path": "schedule/6", "kind": "schedule", "number": "6", "heading": "TRANSITIONAL PROVISIONS", "url": null, "extent": null, "status": null, "parent": null }, { "path": "schedule/6/paragraph/1", "kind": "paragraph", "number": "1", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-6/paragraph-1", "extent": null, "status": null, "parent": "schedule/6" }, { "path": "schedule/6/paragraph/2", "kind": "paragraph", "number": "2", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-6/paragraph-2", "extent": null, "status": null, "parent": "schedule/6" }, { "path": "schedule/6/paragraph/3", "kind": "paragraph", "number": "3", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-6/paragraph-3", "extent": null, "status": null, "parent": "schedule/6" }, { "path": "schedule/6/paragraph/4", "kind": "paragraph", "number": "4", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-6/paragraph-4", "extent": null, "status": null, "parent": "schedule/6" }, { "path": "schedule/6/paragraph/5", "kind": "paragraph", "number": "5", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-6/paragraph-5", "extent": null, "status": null, "parent": "schedule/6" }, { "path": "schedule/7", "kind": "schedule", "number": "7", "heading": "CONSEQUENTIAL AMENDMENTS TO REGULATIONS", "url": null, "extent": null, "status": null, "parent": null }, { "path": "schedule/7/paragraph/1", "kind": "paragraph", "number": "1", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-1", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/2", "kind": "paragraph", "number": "2", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-2", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/3", "kind": "paragraph", "number": "3", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-3", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/4", "kind": "paragraph", "number": "4", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-4", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/5", "kind": "paragraph", "number": "5", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-5", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/6", "kind": "paragraph", "number": "6", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-6", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/7", "kind": "paragraph", "number": "7", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-7", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/8", "kind": "paragraph", "number": "8", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-8", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/9", "kind": "paragraph", "number": "9", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-9", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/10", "kind": "paragraph", "number": "10", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-10", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/11", "kind": "paragraph", "number": "11", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-11", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/12", "kind": "paragraph", "number": "12", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-12", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/13", "kind": "paragraph", "number": "13", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-13", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/14", "kind": "paragraph", "number": "14", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-14", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/15", "kind": "paragraph", "number": "15", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-15", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/16", "kind": "paragraph", "number": "16", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-16", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/17", "kind": "paragraph", "number": "17", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-17", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/18", "kind": "paragraph", "number": "18", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-18", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/19", "kind": "paragraph", "number": "19", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-19", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/20", "kind": "paragraph", "number": "20", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-20", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/21", "kind": "paragraph", "number": "21", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-21", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "schedule/7/paragraph/22", "kind": "paragraph", "number": "22", "heading": null, "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-7/paragraph-22", "extent": null, "status": null, "parent": "schedule/7" }, { "path": "note", "kind": "note", "number": null, "heading": "Explanatory note", "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/note", "extent": null, "status": null, "parent": null } ], "has_text": true, "pdfs": [], "outstanding_effects": [ { "type": "reserved", "affected_provisions": "Regulations", "affecting": "ukpga/1998/46", "affecting_title": "Scotland Act 1998", "affecting_provisions": "Sch. 5 Pt. 2 s. J4(a)" }, { "type": "revoked", "affected_provisions": "Sch. 7 para. 11", "affecting": "uksi/1996/1499", "affecting_title": "The Food Labelling Regulations 1996", "affecting_provisions": "Sch. 9" }, { "type": "revoked", "affected_provisions": "Sch.7, para.22", "affecting": "uksi/1997/2884", "affecting_title": "The Medicines (Restrictions on the Administration of Veterinary Medicinal Products) Amendment Regulations 1997", "affecting_provisions": "reg.4" }, { "type": "amended", "affected_provisions": "Sch.5, para.5(2)(b)", "affecting": "uksi/1998/3105", "affecting_title": "The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998", "affecting_provisions": "reg.3(2)" }, { "type": "added", "affected_provisions": "Sch.5, para.5(1)(f)(g)", "affecting": "uksi/1998/3105", "affecting_title": "The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998", "affecting_provisions": "reg.3(1)" }, { "type": "amended", "affected_provisions": "Sch.3, para.12", "affecting": "uksi/1998/3105", "affecting_title": "The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998", "affecting_provisions": "reg.5(2)" }, { "type": "amended", "affected_provisions": "Sch.3, para.11", "affecting": "uksi/1998/3105", "affecting_title": "The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998", "affecting_provisions": "reg.5(1)" }, { "type": "amended", "affected_provisions": "reg.11", "affecting": "uksi/1998/3105", "affecting_title": "The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998", "affecting_provisions": "reg.2" }, { "type": "added", "affected_provisions": "Sch.5A", "affecting": "uksi/1998/3105", "affecting_title": "The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998", "affecting_provisions": "reg.4" }, { "type": "revoked", "affected_provisions": "Sch.7, paras.12,19", "affecting": "uksi/1999/1540", "affecting_title": "The Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations 1999", "affecting_provisions": "reg.21, Sch.4" }, { "type": "revoked", "affected_provisions": "Sch. 7 para. 12", "affecting": "uksi/1999/1540", "affecting_title": "The Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations 1999", "affecting_provisions": "Sch. 4" }, { "type": "revoked", "affected_provisions": "Sch. 7 para. 19", "affecting": "uksi/1999/1540", "affecting_title": "The Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations 1999", "affecting_provisions": "Sch. 4" }, { "type": "applied", "affected_provisions": "reg.1 defn(s).", "affecting": "uksi/1999/2109", "affecting_title": "The Medicines (Aristolochia) (Emergency Prohibition) Order 1999", "affecting_provisions": "art.2(4)" }, { "type": "amended", "affected_provisions": "Sch.3. para.6", "affecting": "uksi/2000/292", "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000", "affecting_provisions": "reg 4(2)" }, { "type": "amended", "affected_provisions": "reg.1 defn(s).", "affecting": "uksi/2000/292", "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000", "affecting_provisions": "reg 2" }, { "type": "added", "affected_provisions": "reg.3A", "affecting": "uksi/2000/292", "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000", "affecting_provisions": "reg.3" }, { "type": "added", "affected_provisions": "Sch.3. para.1 A", "affecting": "uksi/2000/292", "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000", "affecting_provisions": "reg 4(1)" }, { "type": "amended", "affected_provisions": "Sch.5, para 5", "affecting": "uksi/2000/292", "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000", "affecting_provisions": "reg 5" }, { "type": "subst", "affected_provisions": "reg 1 defn(s)", "affecting": "uksi/2001/795", "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001", "affecting_provisions": "reg 2(1)(d)" }, { "type": "am", "affected_provisions": "reg 5", "affecting": "uksi/2001/795", "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001", "affecting_provisions": "reg 2(3)" }, { "type": "am", "affected_provisions": "reg 4", "affecting": "uksi/2001/795", "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001", "affecting_provisions": "reg 2(2)" }, { "type": "added", "affected_provisions": "reg 1 defn(s)", "affecting": "uksi/2001/795", "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001", "affecting_provisions": "reg 2(1)(a), (b)" }, { "type": "rev", "affected_provisions": "reg 1 defn(s)", "affecting": "uksi/2001/795", "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001", "affecting_provisions": "reg 2(1)(c)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 9", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(h)(iv)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 8", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(h)(iv)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 7", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(h)(iv)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 6(c)", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(h)(iii)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 6(e)", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(h)(ii)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 6(b)", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(h)(ii)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 12", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(h)(vi)" }, { "type": "words substituted", "affected_provisions": "Sch. 5 para. 2", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(i)(i)" }, { "type": "words substituted", "affected_provisions": "Sch. 5 para. 2", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(i)(ii)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 6(a)", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(h)(i)" }, { "type": "words substituted", "affected_provisions": "Sch. 2 para. 4(b)", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(g)(iii)" }, { "type": "words substituted", "affected_provisions": "reg. 4(6)", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(b)" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(a)(i)" }, { "type": "words substituted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(a)(iii)" }, { "type": "substituted for words in Sch. 3 para. 10(c)", "affected_provisions": "Sch. 3 para. 10(d) and words", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(h)(v)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 10", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(h)(iv)" }, { "type": "words substituted", "affected_provisions": "Sch. 2 para. 4(a)", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(g)(ii)" }, { "type": "words substituted", "affected_provisions": "Sch. 2 para. 3", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(g)(i)" }, { "type": "words substituted", "affected_provisions": "reg. 5(4)", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(d)" }, { "type": "words substituted", "affected_provisions": "reg. 8(2)", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(e)" }, { "type": "words substituted", "affected_provisions": "Sch. 1 para. 2(e)", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(f)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 11", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(h)(vi)" }, { "type": "words substituted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2002/236", "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002", "affecting_provisions": "reg. 8(a)(ii)" }, { "type": "appl (13.1.2003)", "affected_provisions": "reg 1 defn(s)", "affecting": "uksi/2002/3170", "affecting_title": "The Medicines for Human Use (Kava-kava) (Prohibition) Order 2002", "affecting_provisions": "art 3(d)(ii)" }, { "type": "rev in pt", "affected_provisions": "reg 6", "affecting": "uksi/2002/542", "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002", "affecting_provisions": "reg 3(1), (4)" }, { "type": "added", "affected_provisions": "reg 5A", "affecting": "uksi/2002/542", "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002", "affecting_provisions": "reg 3(1), (3)" }, { "type": "rev in pt", "affected_provisions": "reg 5", "affecting": "uksi/2002/542", "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002", "affecting_provisions": "reg 3(1), (2)" }, { "type": "rev", "affected_provisions": "reg 8", "affecting": "uksi/2002/542", "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002", "affecting_provisions": "reg 3(1), (5)" }, { "type": "am", "affected_provisions": "Sch 5, para 6", "affecting": "uksi/2002/542", "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002", "affecting_provisions": "reg 3(1), (6)" }, { "type": "added", "affected_provisions": "Sch 5A, para 3", "affecting": "uksi/2003/1618", "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2003", "affecting_provisions": "reg 3" }, { "type": "am", "affected_provisions": "Sch 5, para 5", "affecting": "uksi/2003/1618", "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2003", "affecting_provisions": "reg 2" }, { "type": "rev", "affected_provisions": "Sch 7, para 2", "affecting": "uksi/2003/2317", "affecting_title": "The Medicines (Child Safety) Regulations 2003", "affecting_provisions": "reg 7(e)" }, { "type": "am", "affected_provisions": "Sch 3, para 6", "affecting": "uksi/2003/2321", "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003", "affecting_provisions": "reg 7(1), (4)(b)" }, { "type": "am", "affected_provisions": "reg 1 defn(s)", "affecting": "uksi/2003/2321", "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003", "affecting_provisions": "reg 7(1), (2)(a)(i)" }, { "type": "rev in pt", "affected_provisions": "reg 1 defn(s)", "affecting": "uksi/2003/2321", "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003", "affecting_provisions": "reg 7(1), (2)(a)(ii)(aa)" }, { "type": "am", "affected_provisions": "reg 1 defn(s)", "affecting": "uksi/2003/2321", "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003", "affecting_provisions": "reg 7(1), (2)(a)(ii)(bb)" }, { "type": "am", "affected_provisions": "reg 1", "affecting": "uksi/2003/2321", "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003", "affecting_provisions": "reg 7(1), (2)(b)" }, { "type": "added", "affected_provisions": "reg 6A", "affecting": "uksi/2003/2321", "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003", "affecting_provisions": "reg 7(3)" }, { "type": "added", "affected_provisions": "Sch 3, para 3A", "affecting": "uksi/2003/2321", "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003", "affecting_provisions": "reg 7(1), (4)(a)" }, { "type": "words omitted", "affected_provisions": "reg. 1(5)", "affecting": "uksi/2004/1031", "affecting_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004", "affecting_provisions": "Sch. 10 Pt. 2 para. 12(a)(ii)" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2004/1031", "affecting_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004", "affecting_provisions": "Sch. 10 Pt. 2 para. 12(a)(i)" }, { "type": "substituted", "affected_provisions": "Sch. 1 para. 2(e)", "affecting": "uksi/2004/1031", "affecting_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004", "affecting_provisions": "Sch. 10 Pt. 2 para. 12(b)" }, { "type": "omitted", "affected_provisions": "reg. 9(14)", "affecting": "uksi/2004/2990", "affecting_title": "The Food Safety Act 1990 (Amendment) Regulations 2004", "affecting_provisions": "reg. 7" }, { "type": "words substituted", "affected_provisions": "Sch. 2 para. 3", "affecting": "uksi/2004/3224", "affecting_title": "The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004", "affecting_provisions": "reg. 3(3)" }, { "type": "inserted", "affected_provisions": "reg. 1(5A)", "affecting": "uksi/2004/3224", "affecting_title": "The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004", "affecting_provisions": "reg. 3(2)(b)" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2004/3224", "affecting_title": "The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004", "affecting_provisions": "reg. 3(2)(a)(v)(bb)" }, { "type": "words substituted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2004/3224", "affecting_title": "The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004", "affecting_provisions": "reg. 3(2)(a)(iii)" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2004/3224", "affecting_title": "The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004", "affecting_provisions": "reg. 3(2)(a)(iv)" }, { "type": "word omitted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2004/3224", "affecting_title": "The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004", "affecting_provisions": "reg. 3(2)(a)(v)(aa)" }, { "type": "inserted", "affected_provisions": "Sch. 6 para. 4A", "affecting": "uksi/2004/3224", "affecting_title": "The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004", "affecting_provisions": "reg. 3(5)" }, { "type": "inserted", "affected_provisions": "Sch. 3 para. 6A", "affecting": "uksi/2004/3224", "affecting_title": "The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004", "affecting_provisions": "reg. 3(4)(b)" }, { "type": "inserted", "affected_provisions": "Sch. 3 para. 6(cc)", "affecting": "uksi/2004/3224", "affecting_title": "The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004", "affecting_provisions": "reg. 3(4)(a)" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2004/3224", "affecting_title": "The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004", "affecting_provisions": "reg. 3(2)(a)(ii)" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2004/3224", "affecting_title": "The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004", "affecting_provisions": "reg. 3(2)(a)(i)" }, { "type": "words substituted", "affected_provisions": "Sch. 1 para. 3(1)(a)", "affecting": "uksi/2004/865", "affecting_title": "The General Medical Services and Personal Medical Services Transitional and Consequential Provisions Order 2004", "affecting_provisions": "Sch. 1 para. 12" }, { "type": "substituted", "affected_provisions": "Sch. 2", "affecting": "uksi/2005/1094", "affecting_title": "The Medicines (Advisory Bodies) Regulations 2005", "affecting_provisions": "Sch. 2 para. 4" }, { "type": "omitted", "affected_provisions": "reg. 9(1)", "affecting": "uksi/2005/1094", "affecting_title": "The Medicines (Advisory Bodies) Regulations 2005", "affecting_provisions": "Sch. 2 para. 3" }, { "type": "words inserted", "affected_provisions": "reg. 5(3)", "affecting": "uksi/2005/1094", "affecting_title": "The Medicines (Advisory Bodies) Regulations 2005", "affecting_provisions": "Sch. 2 para. 2" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2005/1094", "affecting_title": "The Medicines (Advisory Bodies) Regulations 2005", "affecting_provisions": "Sch. 2 para. 1" }, { "type": "added", "affected_provisions": "reg 1 defn(s)", "affecting": "uksi/2005/1520", "affecting_title": "The Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2005", "affecting_provisions": "reg 2(a)" }, { "type": "rev in pt", "affected_provisions": "reg 1 defn(s)", "affecting": "uksi/2005/1520", "affecting_title": "The Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2005", "affecting_provisions": "reg 2(b)(i), (c)(i)" }, { "type": "am", "affected_provisions": "reg 1 defn(s)", "affecting": "uksi/2005/1520", "affecting_title": "The Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2005", "affecting_provisions": "reg 2(b)(ii), (iii), (c)(ii), (iii)" }, { "type": "added", "affected_provisions": "Sch 3, para 10A", "affecting": "uksi/2005/1710", "affecting_title": "The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005", "affecting_provisions": "reg 3(a)" }, { "type": "added", "affected_provisions": "Sch 3, para 13A", "affecting": "uksi/2005/1710", "affecting_title": "The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005", "affecting_provisions": "reg 3(b)" }, { "type": "am", "affected_provisions": "Sch 3, para 15", "affecting": "uksi/2005/1710", "affecting_title": "The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005", "affecting_provisions": "reg 3(c)" }, { "type": "added", "affected_provisions": "Sch 3, para 17", "affecting": "uksi/2005/1710", "affecting_title": "The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005", "affecting_provisions": "reg 3(d)" }, { "type": "substituted", "affected_provisions": "Sch. 2 para. 2(a)", "affecting": "uksi/2005/2754", "affecting_title": "The Medicines (Advisory Bodies) (No. 2) Regulations 2005", "affecting_provisions": "Sch. 2 para. 1(2)" }, { "type": "word substituted", "affected_provisions": "Sch. 2 para. 14(8)(a)", "affecting": "uksi/2005/2754", "affecting_title": "The Medicines (Advisory Bodies) (No. 2) Regulations 2005", "affecting_provisions": "Sch. 2 para. 1(3)" }, { "type": "words substituted", "affected_provisions": "reg. 3(1)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(3)" }, { "type": "substituted for reg. 4(3)(4)", "affected_provisions": "reg. 4(3)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(6)(a)" }, { "type": "substituted", "affected_provisions": "reg. 4(6)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(6)(b)" }, { "type": "inserted", "affected_provisions": "reg. 4(6A)(6B)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(6)(c)" }, { "type": "word substituted", "affected_provisions": "reg. 4(9)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(6)(d)" }, { "type": "substituted", "affected_provisions": "reg. 5(4)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(7)(a)" }, { "type": "inserted", "affected_provisions": "reg. 5(5)-(9)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(7)(b)" }, { "type": "inserted", "affected_provisions": "reg. 5A(1A)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(8)" }, { "type": "words substituted", "affected_provisions": "reg. 6(5)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(9)(a)" }, { "type": "inserted", "affected_provisions": "reg. 6(7A)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(9)(b)" }, { "type": "words inserted", "affected_provisions": "reg. 6A(1)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(10)(a)" }, { "type": "word omitted", "affected_provisions": "reg. 6A(2)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(10)(b)" }, { "type": "words substituted", "affected_provisions": "reg. 7(1)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(11)(a)" }, { "type": "inserted", "affected_provisions": "reg. 7(3A)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(11)(b)" }, { "type": "inserted", "affected_provisions": "reg. 7(7)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(11)(c)" }, { "type": "words inserted", "affected_provisions": "reg. 9(15)(16)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(12)" }, { "type": "words inserted", "affected_provisions": "Sch. 1 para. 1", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(13)(a)" }, { "type": "substituted", "affected_provisions": "Sch. 1 para. 2(e)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(13)(b)" }, { "type": "inserted", "affected_provisions": "Sch. 1 para. 5A", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(13)(c)" }, { "type": "Sch. 3 para. 1A renumbered as Sch. 3 para. 1A(1)", "affected_provisions": "Sch. 3 para. 1A(1)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(a)(i)" }, { "type": "words inserted", "affected_provisions": "Sch. 3 para. 1A(1)(a)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(a)(ii)" }, { "type": "words inserted", "affected_provisions": "Sch. 3 para. 1A(1)(b)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(a)(iii)" }, { "type": "inserted", "affected_provisions": "Sch. 3 para. 1A(2)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(a)(iv)" }, { "type": "inserted", "affected_provisions": "Sch. 3 para. 1AA", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(b)" }, { "type": "words inserted", "affected_provisions": "Sch. 3 para. 2", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(c)" }, { "type": "inserted", "affected_provisions": "Sch. 3 para. 2A", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(d)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 4", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(e)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 7", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(e)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 8", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(e)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 9", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(e)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 10", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(e)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 6(b)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(f)(i)" }, { "type": "words inserted", "affected_provisions": "Sch. 3 para. 6(cc)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(f)(ii)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 6(e)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(f)(v)" }, { "type": "words inserted", "affected_provisions": "Sch. 3 para. 6A", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(g)" }, { "type": "inserted", "affected_provisions": "Sch. 3 para. 6B–6F", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(h)" }, { "type": "words inserted", "affected_provisions": "Sch. 3 para. 17", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(i)" }, { "type": "inserted", "affected_provisions": "Sch. 3 para. 18 19", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(j)" }, { "type": "inserted", "affected_provisions": "Sch. 6 para. 4B", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(15)" }, { "type": "inserted", "affected_provisions": "Sch. 3 para. 6(dd)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(f)(iv)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 6(d)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(14)(f)(iii)" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(2)(a)(i)" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(2)(a)(ii)" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(2)(a)(iii)(aa)" }, { "type": "words omitted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(2)(a)(iii)(bb)" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(2)(a)(iv)" }, { "type": "words substituted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(2)(a)(v)" }, { "type": "words omitted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(2)(a)(vi)(aa)" }, { "type": "words omitted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(2)(a)(vi)(bb)" }, { "type": "words substituted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(2)(a)(vii)" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(2)(a)(viii)" }, { "type": "omitted", "affected_provisions": "reg. 1(3)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(2)(b)" }, { "type": "omitted", "affected_provisions": "reg. 1(5A)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(2)(c)" }, { "type": "words inserted", "affected_provisions": "reg. 3A(1)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(4)(a)" }, { "type": "words inserted", "affected_provisions": "reg. 3A(6)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(4)(b)" }, { "type": "inserted", "affected_provisions": "reg. 3A(8)", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(4)(c)" }, { "type": "inserted", "affected_provisions": "reg. 3B", "affecting": "uksi/2005/2759", "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg. 2(5)" }, { "type": "am", "affected_provisions": "reg 1 defn(s)", "affecting": "uksi/2005/50", "affecting_title": "The Blood Safety and Quality Regulations 2005", "affecting_provisions": "reg 25(3)" }, { "type": "am", "affected_provisions": "Sch 1, paras 1, 2", "affecting": "uksi/2005/768", "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg 3" }, { "type": "added", "affected_provisions": "reg 1 defn(s)", "affecting": "uksi/2005/768", "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2005", "affecting_provisions": "reg 2" }, { "type": "added", "affected_provisions": "sch 1A", "affecting": "uksi/2006/1952", "affecting_title": "The Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006", "affecting_provisions": "reg 4" }, { "type": "am", "affected_provisions": "reg 1", "affecting": "uksi/2006/1952", "affecting_title": "The Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006", "affecting_provisions": "reg 2" }, { "type": "am", "affected_provisions": "reg 4", "affecting": "uksi/2006/1952", "affecting_title": "The Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006", "affecting_provisions": "reg 3" }, { "type": "am", "affected_provisions": "sch 3", "affecting": "uksi/2006/1952", "affecting_title": "The Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006", "affecting_provisions": "reg 5" }, { "type": "words substituted", "affected_provisions": "Sch. 1 para. 3(1)(a)", "affecting": "uksi/2006/562", "affecting_title": "The General Dental Services, Personal Dental Services and Abolition of the Dental Practice Board Transitional and Consequential Provisions Order 2006", "affecting_provisions": "Sch. 1 para. 4" }, { "type": "word substituted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2006/914", "affecting_title": "The Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2006", "affecting_provisions": "reg. 3(d)(i)" }, { "type": "words omitted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2006/914", "affecting_title": "The Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2006", "affecting_provisions": "reg. 3(a)" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2006/914", "affecting_title": "The Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2006", "affecting_provisions": "reg. 3(d)(ii)" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2006/914", "affecting_title": "The Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2006", "affecting_provisions": "reg. 3(b)" }, { "type": "word substituted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2006/914", "affecting_title": "The Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2006", "affecting_provisions": "reg. 3(c)" }, { "type": "words substituted", "affected_provisions": "reg. 1", "affecting": "uksi/2007/289", "affecting_title": "The Pharmacists and Pharmacy Technicians Order 2007", "affecting_provisions": "Sch. 1 para. 17" }, { "type": "inserted", "affected_provisions": "Sch. 5 para. 9", "affecting": "uksi/2009/1164", "affecting_title": "The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009", "affecting_provisions": "reg. 2" }, { "type": "am (1.1.2010)", "affected_provisions": "sch 2", "affecting": "uksi/2009/2820", "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2009", "affecting_provisions": "reg 2" }, { "type": "am", "affected_provisions": "sch 1", "affecting": "uksi/2009/3063", "affecting_title": "The Medicines for Human Use (Miscellaneous Amendments) (No.2) Regulations 2009", "affecting_provisions": "reg 2" }, { "type": "word substituted", "affected_provisions": "Sch. 3 para. 3A", "affecting": "uksi/2009/3222", "affecting_title": "The Medicines (Products for Human Use) (Amendments to Fees for Variations) Regulations 2009", "affecting_provisions": "reg. 9(4)" }, { "type": "words substituted", "affected_provisions": "Sch. 2 para. 1", "affecting": "uksi/2009/3222", "affecting_title": "The Medicines (Products for Human Use) (Amendments to Fees for Variations) Regulations 2009", "affecting_provisions": "reg. 9(3)" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2009/3222", "affecting_title": "The Medicines (Products for Human Use) (Amendments to Fees for Variations) Regulations 2009", "affecting_provisions": "reg. 9(2)(a)" }, { "type": "words substituted", "affected_provisions": "Sch. 3 para. 15", "affecting": "uksi/2010/1882", "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010", "affecting_provisions": "Sch. 5 para. 3(5)" }, { "type": "applied (with modifications)", "affected_provisions": "Sch. 3 para. 13C", "affecting": "uksi/2010/1882", "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010", "affecting_provisions": "reg. 5" }, { "type": "words revoked", "affected_provisions": "Sch. 1 para. 2(b)", "affecting": "uksi/2010/1882", "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010", "affecting_provisions": "Sch. 5 para. 2" }, { "type": "applied (with modifications)", "affected_provisions": "Sch. 3 para. 17", "affecting": "uksi/2010/1882", "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010", "affecting_provisions": "reg. 5" }, { "type": "inserted", "affected_provisions": "Sch. 3 para. 10B", "affecting": "uksi/2010/1882", "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010", "affecting_provisions": "Sch. 5 para. 3(2)" }, { "type": "inserted", "affected_provisions": "Sch. 6 para. 6", "affecting": "uksi/2010/1882", "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010", "affecting_provisions": "Sch. 5 para. 4" }, { "type": "inserted", "affected_provisions": "Sch. 3 para. 13C", "affecting": "uksi/2010/1882", "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010", "affecting_provisions": "Sch. 5 para. 3(4)" }, { "type": "applied (with modifications)", "affected_provisions": "Sch. 3 para. 14", "affecting": "uksi/2010/1882", "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010", "affecting_provisions": "reg. 5" }, { "type": "words inserted", "affected_provisions": "Sch. 3 para. 11", "affecting": "uksi/2010/1882", "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010", "affecting_provisions": "Sch. 5 para. 3(3)" }, { "type": "words inserted", "affected_provisions": "Sch. 3 para. 12", "affecting": "uksi/2010/1882", "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010", "affecting_provisions": "Sch. 5 para. 3(3)" }, { "type": "word revoked", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2010/1882", "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010", "affecting_provisions": "Sch. 5 para. 1(d)(i)" }, { "type": "words substituted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2010/1882", "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010", "affecting_provisions": "Sch. 5 para. 1(b)" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2010/1882", "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010", "affecting_provisions": "Sch. 5 para. 1(d)(ii)" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2010/1882", "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010", "affecting_provisions": "Sch. 5 para. 1(c)" }, { "type": "words inserted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2010/1882", "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010", "affecting_provisions": "Sch. 5 para. 1(a)" }, { "type": "words substituted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2010/231", "affecting_title": "The Pharmacy Order 2010", "affecting_provisions": "Sch. 4 para. 26" }, { "type": "words substituted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2012/1479", "affecting_title": "The Health and Social Care Act 2012 (Consequential Provision—Social Workers) Order 2012", "affecting_provisions": "Sch. para. 11(b)" }, { "type": "words substituted", "affected_provisions": "reg. 1(2)", "affecting": "uksi/2012/1479", "affecting_title": "The Health and Social Care Act 2012 (Consequential Provision—Social Workers) Order 2012", "affecting_provisions": "Sch. para. 11(a)" }, { "type": "revoked", "affected_provisions": "Regulations", "affecting": "uksi/2012/1916", "affecting_title": "The Human Medicines Regulations 2012", "affecting_provisions": "Sch. 35" }, { "type": "words substituted", "affected_provisions": "Sch. 1 para. 3(1)(a)", "affecting": "wsi/2004/1016", "affecting_title": "The General Medical Services Transitional and Consequential Provisions (Wales) (No. 2) Order 2004", "affecting_provisions": "Sch. 1 para. 12" } ], "made_under": [ { "id": "ukpga/1972/68", "title": "European Communities Act 1972 (repealed)", "url": "https://openlegislation.uk/european-communities-act-1972-repealed", "provisions": [ "section/2" ] } ], "changes_made_to": 188, "changes_made_to_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/changes.json", "changes_made_by": 39, "changes_made_by_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/changes/by-it.json", "instruments_made_under": 0, "instruments_made_under_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/instruments.json", "provenance": { "source": "legislation.gov.uk", "source_url": "https://www.legislation.gov.uk/uksi/1994/3144", "retrieved_at": "2026-10-29T13:21:07.489272+00:00" }, "licence": "Open Government Licence v3.0", "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/", "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives." }