{
  "url": "https://openlegislation.uk/national-health-service-serious-shortage-protocols-miscellaneous-amendments-scotland-regulations-2019/note",
  "json_url": "https://openlegislation.uk/national-health-service-serious-shortage-protocols-miscellaneous-amendments-scotland-regulations-2019/note.json",
  "legislation": "ssi/2019/284",
  "legislation_title": "The National Health Service (Serious Shortage Protocols) (Miscellaneous Amendments) (Scotland) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/national-health-service-serious-shortage-protocols-miscellaneous-amendments-scotland-regulations-2019",
  "path": "note",
  "kind": "note",
  "number": null,
  "heading": "Explanatory note",
  "text": "(This note is not part of the Regulations)\nThese Regulations amend the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009 (“the 2009 Regulations”), the National Health Service (General Medical Services Contracts) (Scotland) Regulations 2018 (“the GMS Contracts Regulations”) and the National Health Services (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2018 (“the Section 17C Agreements Regulations”).\nThese Regulations amend the 2009 Regulations to allow pharmacists to supply prescription only medicines in accordance with a serious shortage protocol (“SSP”) issued in accordance with regulation 226A of the Human Medicines Regulations 2012. These Regulations also amend the 2009 Regulations, the GMS Contracts Regulations and the Section 17C Agreements Regulations to allow pharmacists and dispensing doctors to supply drugs and appliances, which are not prescription only medicines, in accordance with a Scottish serious shortage protocol (“Scottish SSP”). Similar provisions have been included for England in the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, as amended by the National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019.\nRegulations 3 and 4 amend the 2009 Regulations.\nRegulation 3 inserts new definitions into regulation 2(1) of the 2009 Regulations for “prescription only medicine”, “Scottish SSP”, “serious shortage protocol”, and “SSP”.\nRegulation 4(b) inserts new sub-paragraphs (30) to (38) into paragraph 4 of schedule 1 of the 2009 Regulations which provide as follows—\nSub-paragraphs (30) to (33) allow pharmacists to supply prescription only medicines in accordance with a SSP and other drugs and appliances in accordance with a Scottish SSP provided certain conditions are satisfied.\nSub-paragraph (34) provides that where a pharmacist is of the opinion, in the exercise of their reasonable skill and judgement, that it is unreasonable or inappropriate to supply in accordance with a SSP or Scottish SSP, and they are able to supply the prescription only medicine or other drug or appliance ordered by the prescriber or dentist within a reasonable timescale, the requirements to act with reasonable promptness in paragraph 4(1), (1A)(a) and (3) of schedule 1 of the 2009 Regulations are to be read as requirements to act within a reasonable timescale.\nSub-paragraph (35) makes provision for when a pharmacist is required to refuse to supply a prescription only medicine or other drug or appliance ordered on a prescription form or serial prescription.\nSub-paragraph (36) makes provision for when a pharmacist may refuse to supply a prescription only medicine or other drug or appliance ordered on a prescription form or serial prescription.\nSub-paragraph (37) provides that where a pharmacist refuses to supply a prescription only medicine or other drug or appliance under sub-paragraph (36), the pharmacist must contact the prescriber or dentist to discuss alternative arrangements.\nSub-paragraph (38) requires a pharmacist who supplies a prescription only medicine in accordance with a SSP, or other drug or appliance in accordance with a Scottish SSP, to include in the dispensing label on the packaging of the prescription only medicine or other drug or appliance, information to the effect that it is being supplied in accordance with a SSP or a Scottish SSP. The pharmacist is also required to supply the prescription only medicine or other drug or appliance in a suitable container.\nRegulation 4(a) makes a minor and consequential amendment to paragraph 4(23) of schedule 1 of the 2009 Regulations.\nRegulations 6 and 7 amend the GMS Contracts Regulations.\nRegulation 6 inserts a new definition into regulation 3(1) of the GMS Contracts Regulations for “Scottish SSP”.\nRegulation 7 inserts new sub-paragraph (11) into paragraph 44 of schedule 6 of the GMS Contracts Regulations. Sub-paragraph (11) allows a contractor who is required or authorised by the Health Board to supply drugs, medicines and appliances to do so in accordance with a Scottish SSP.\nRegulations 9 and 10 amend the Section 17C Agreements Regulations.\nRegulation 9 inserts a new definition into regulation 3(1) of the Section 17C Agreements Regulations for “Scottish SSP”.\nRegulation 10 inserts new sub-paragraph (11) into paragraph 16 of schedule 1 of the Section 17C Agreements Regulations. Sub-paragraph (11) allows a provider who is required or authorised by the Health Board to supply drugs, medicines and appliances to do so in accordance with a Scottish SSP.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ssi/2019/284/note",
    "retrieved_at": "2026-10-28T21:06:09.215836+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."
}