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SCOTTISH STATUTORY INSTRUMENTS

2007 No. 139
NATIONAL HEALTH SERVICE
The National Health Service (Charges for Drugs and Appliances) (Scotland) Regulations 2007

	Made	6th March 2007
	Laid before the Scottish Parliament	8th March 2007
	Coming into force	1st April 2007

ARRANGEMENT OF REGULATIONS

1.	Citation and commencement

2.	Interpretation

3.	Supply of drugs and appliances by chemists

4.	Supply of drugs and appliances by doctors

5.	Supply of drugs and appliances to out-patients

6.	Fabric supports and wigs

7.	Exemptions

8.	Pre-payment certificates

9.

Refunds

10.	Revocations and savings

SCHEDULE 1 —

CHARGES FOR ELASTIC HOSIERY

SCHEDULE 2 —

CHARGES FOR TIGHTS

SCHEDULE 3 —

CHARGES; FOR FABRIC SUPPORTS AND WIGS

SCHEDULE 4 —

REVOCATIONS

The Scottish Ministers, in exercise of the powers conferred by sections 25(2), 27(2), 69(1) and (2), 75(a), 105(7) and 108(1) of the National Health Service (Scotland) Act 1978[1] and of all other powers enabling them in that behalf, hereby make the following Regulations:

Citation and commencement
1. These Regulations may be cited as the National Health Service (Charges for Drugs and Appliances) (Scotland) Regulations 2007 and shall come into force on 1st April 2007.

Interpretation
2. —(1) In these Regulations–

"the Act" means the National Health Service (Scotland) Act 1978;

"the 2001 Regulations" means the National Health Service (Charges for Drugs and Appliances) (Scotland) Regulations 2001[

2

"accepted disablement" means physical or mental injury or disease which is accepted by the Secretary of State as attributable to or aggravated by service in the armed forces of the Crown or such other service as the Secretary of State may determine;

"advanced electronic signature" means an electronic signature which is–

"appliance" means an appliance, other than a contraceptive appliance, which is a listed appliance within the meaning of section 27(1) of the Act;

"chemist" includes any person, other than a doctor, providing pharmaceutical services;

"dentist" means a registered dental practitioner;

"doctor" means a registered medical practitioner;

"drugs" includes medicines but does not include contraceptive substances;

"elastic hosiery" means anklet, legging, knee-cap, below-knee or thigh stocking;

3

"electronic prescription form" means a prescription form as defined in paragraph (b) of the definition of "prescription form";

"electronic signature" has the meaning attributed to it in section 7(2) of the Electronic Communications Act 2000;

"e-Pharmacy Service" means the electronic system provided by the Agency by which electronic prescription forms are transmitted;

"exemption" means any remission granted under or by virtue of these Regulations;

"exemption certificate" means a certificate issued under these Regulations authorising a person to claim exemption from charges payable under these Regulations;

4

"GMS contractor" means a party to a GMS contract other than a Health Board;

5

"independent nurse prescriber" means a person–

"non-electronic prescription form" means a prescription form as defined in paragraph (a) of the definition of "prescription form";

6

"out-patient" means a person receiving treatment under the Act otherwise than under Part II of the Act and who is not for the purpose of receiving that treatment resident in a hospital;

"patient" means–

7

"pharmaceutical services" means services provided under section 27 of the Act;

"pharmacist" means a pharmacist within the meaning of section 132(1) of the Medicines Act 1968;

8

"prescriber" means a doctor, an independent nurse prescriber or a supplementary prescriber;”

"prescription form" means–

(ii) which contains on its reverse side a form of declaration of entitlement to exemption or a statement that a charge has been paid;

and includes a prescription form provided and issued under equivalent arrangements having effect in England, Wales and Northern Ireland; or

(b) data that are created in an electronic form for the provision of pharmaceutical services ordered by–

and signed with such person's advanced electronic signature and transmitted as an electronic communication through the ePharmacy service; or

(c) a form on which domiciliary oxygen has been ordered–

9

"supplementary prescriber" means a person whose name is registered in–

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(e) the register of optometrists maintained by the General Optical Council in pursuance of section 7 of the Opticians Act 1989[13],

and against whose name is recorded in the relevant register an annotation signifying that he or she is qualified to order drugs, medicines and appliances as a supplementary prescriber or, in the case of the Nursing and Midwifery Register, a nurse independent/supplementary prescriber;

"treatment" includes examination and diagnosis.

(2) For the purpose of these Regulations–

    (3) For as long as there are in existence contracts entered into under article 13 of the General Medical Services (Transitional and Other Ancillary Provisions) (Scotland) Order 2004[18] ("default contracts") any reference in these Regulations to a GMS contract shall be read as including a reference to a contract entered into under that article and any reference to a term of a GMS contract shall be read as including a reference to the equivalent term of the default contract.

    (4) For as long as there are in existence transitional agreements as defined in article 1(2) of the General Medical Services and Section 17C Agreements (Transitional and Other Ancillary Provisions) (Scotland) Order 2004[19], any reference in these Regulations to a section 17C agreement shall be read as including a reference to a transitional agreement and any reference to a term of a section 17C agreement shall be read as including a reference to any equivalent term in the transitional agreement.

    (5) In these Regulations–

Supply of drugs and appliances by chemists
3. —(1) A chemist who provides pharmaceutical services to a patient shall make and recover from the patient–

(a) in respect of the supply of an appliance specified in column 1 of Schedule 1 the charge specified in column 2 of Schedule 1 in respect of that appliance; and

(b) in any other case, in respect of the supply of each quantity of a drug and each appliance not so specified, a charge of £6.85,

except where–

(i) a declaration of entitlement to exemption on a non-electronic prescription form, or on a supply form, or a declaration of entitlement in respect of pharmaceutical services ordered on an electronic prescription form, is duly completed and signed by or on behalf of the patient; or

(ii) a declaration of entitlement to exemption is duly completed and signed in respect of an order for domiciliary oxygen issued by a prescriber in England or Wales for a patient normally resident in England or Wales.

    (2) For the purposes of this regulation, where a quantity of a drug ordered on one prescription form to be supplied by instalments during a period of not more than 14 days is supplied, only one charge shall be payable and it shall be payable upon the supply of the first instalment.

    (3) A chemist shall be under no obligation to provide pharmaceutical services in respect of an order on a prescription form, or in terms of a Patient Group Direction, unless the patient has paid the chemist any charge payable under paragraph (1), or one of the exceptions set out in paragraph (1) applies.

    (4) A chemist who makes and recovers a charge under paragraph (1) or (2) shall, if required by the patient, give the patient a receipt for the amount paid, on a form provided for the purpose by the Health Board, which contains forms of declaration in support of an application for a refund.

    (5) Any sum which a Health Board is under a duty to pay or cause to be paid to a chemist in respect of the provision by the chemist of pharmaceutical services, other than such provision to which the exceptions set out in paragraph (1) apply, shall be reduced by the sum specified in paragraph (1)(b) in respect of each quantity of a drug supplied and by the sum specified in paragraph (1)(b), or as the case may require, the sum specified in column 2 of Schedule 1 in respect of each appliance supplied as part of such services.

Supply of drugs and appliances by doctors
     4. —(1) A doctor, who provides services corresponding to pharmaceutical services under the terms of a GMS contract which give effect to paragraph 44 of Schedule 5 to the National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004[20] or under the terms of a section 17C agreement which give effect to paragraph 15 of Schedule 1 to the National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004[21] shall make and recover from the patient–

except where the patient or a person on the patient's behalf declares that the patient is entitled to exemption.

    (2) For the purposes of this regulation, where a doctor supplies a quantity of a drug by instalments during a period of not more than 14 days, only one charge shall be payable and it shall be payable upon the supply of the first instalment.

    (3) A doctor shall be under no obligation to supply drugs or appliances unless the patient has paid the doctor any charge payable under paragraph (1), or one of the exceptions set out in paragraph (1) applies.

    (4) After the end of each month, a GMS contractor or section 17C provider shall send the total charges recovered by a doctor during the month to the Health Board with which the GMS contractor or section 17C provider has a GMS contract or section 17C agreement.

    (5) A doctor who makes and recovers a charge under paragraph (1) or (2) shall, if required by the patient, give the patient a receipt for the amount paid, on a form provided for the purpose by the Health Board, which contains forms of declaration in support of an application for a refund.

Supply of drugs and appliances to out-patients
     5. —(1) A Health Board which supplies an out-patient attending hospital with appliances or drugs (to be administered outwith the hospital), shall make and recover from the out-patient–

(a) in respect of the supply of an appliance specified in column 1 of Schedule 1 or Schedule 2, the charge specified in column 2 of Schedule 1 or Schedule 2 in respect of that appliance; and

(b) in respect of the supply of each quantity of a drug and each appliance not so specified, a charge of £6.85,

except where the out-patient or person on the out-patient's behalf, declares that the out-patient is entitled to exemption.

    (2) For the purposes of this regulation, where a quantity of a drug supplied by a hospital against an order on one prescription form is to be supplied by instalments during a period of not more than 14 days, only one charge shall be payable and it shall be payable upon the supply of the first instalment.

    (3) A Health Board which makes and recovers a charge under paragraph (1) or (2) shall, if required by the patient, give the patient a receipt for the amount paid, on a form provided for the purpose by the Health Board, which contains forms of declaration in support of an application for a refund.

Fabric supports and wigs
     6. —(1) A Health Board which, otherwise than under Part II of the Act, supplies a patient with an appliance specified in column 1 of Schedule 3, shall make and recover from the patient the charge specified in column 2 of Schedule 3 in respect of that appliance.

    (2) A Health Board which makes and recovers a charge under paragraph (1) shall, if required by the patient, give the patient a receipt for the amount paid, on a form provided for the purpose by the Health Board, which contains forms of declaration in support of an application for a refund.

Exemptions
     7. —(1) Subject to the provisions of paragraphs 1(1) and 4 of Schedule 11 to the Act and to the following provisions of this regulation, no charge shall be payable under these Regulations by–

(a) a person who is under the age of 16 years;

(b) a person who is under the age of 19 years and is receiving qualifying full time education within the meaning of paragraph 7 of Schedule 11 to the Act[

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(f) a person to whom the Secretary of State has issued a valid exemption certificate in respect of the supply of drugs and appliances for the treatment of accepted disablement but only in respect of those supplies to which the certificate relates; or

(g) a person to whom a pre-payment certificate has been granted pursuant to regulation 8.

(2) No exemption from a charge payable under these Regulations shall be granted unless–

(b) in the case of a charge payable to a doctor, a declaration of entitlement to exemption, which shall be in writing if the doctor so requires, is made to that doctor by the patient or the patient's representative; or

(c) in the case of a charge payable to a Health Board under regulation 5, the person claiming exemption provides such evidence as the Health Board may reasonably require that the person is entitled to such exemption.

(3) A person who wishes to claim exemption under paragraph (1)(d) or (1)(e) shall apply to the Health Board for an exemption certificate on a form provided by the Health Board for that purpose.

(4) If the Health Board is satisfied that an applicant is entitled to exemption from charges under paragraph (1)(d), it shall issue an exemption certificate which shall have effect in the case of an expectant mother until the end of her pregnancy, and–

    (5) If a Health Board is satisfied that an applicant is entitled to exemption under paragraph (1)(e), it shall issue an exemption certificate to the applicant which shall have effect for such period as it may determine.

    (6) Where a claim for exemption has been made but is not substantiated and in consequence of that claim a chemist, a doctor or a Health Board has not recovered a charge in respect of the supply of any drugs or appliances, the Health Board shall recover such charge from the person concerned.

    (7) Any claim for exemption by reference to patient's age or the validity of an exemption certificate shall be determined by reference to the age or validity on the date on which any order for drugs or appliances is presented for dispensing or drugs or appliances are supplied by a doctor or a Health Board.

    (8) The charges which may be made and recovered by virtue of these Regulations are subject to the provisions of the Travelling Expenses and Remission of Charges Regulations.

Pre-payment certificates
     8. —(1) Any person may apply for a pre-payment certificate on completion of a form provided for that purpose by the Health Board.

    (2) A pre-payment certificate shall be valid for a period of either 4 months or 12 months and an application under paragraph (1) shall state the period for which it is required to be valid.

    (3) Any application under paragraph (1) shall be made less than one month before the date on which its period of validity is to begin.

    (4) A pre-payment certificate shall be granted either–

(a) by a Health Board as soon as reasonably practicable following; or

(b) by a pharmacist or doctor duly approved by a Health Board to grant such certificates immediately upon,

payment of the sum of £35.85 for a certificate valid for 4 months or £98.70 for a certificate valid for 12 months.

(5) The payment of a sum prescribed under this regulation shall not be deemed to be the payment of a charge under these Regulations.

(6) Where not more than one month after the date on which a person's pre-payment certificate became valid the person–

(a) becomes a person to whom any of the provisions of regulation 7(1)(b) to (f) applies;

(b) becomes a person entitled to remission under regulation 3 (entitlement to full remission and payment) of the Travelling Expenses and Remission of Charges Regulations;

(c) dies; or

(d) becomes resident in a hospital and thereafter either–

an application for a refund of the sum prescribed by this regulation may be made, by or on behalf of that person or that person's estate, in accordance with paragraphs (11) to (13).

(7) Where a person dies or becomes resident in hospital and thereafter dies during the period of validity of a pre-payment certificate, excluding the month in respect of which an application under paragraph (6) may be made, an application for a refund may be made by or on behalf of that person's estate in accordance with paragraphs (11) to (13).

(8) The refund referred to in paragraph (7) shall be–

(a) in the case of a pre-payment certificate valid for 4 months, 25 per cent of the sum prescribed under this regulation for each complete month after the date of death during which the pre-payment certificate would have remained valid;

(b) in the case of a pre-payment certificate valid for 12 months, 50 per cent of the sum prescribed under this regulation for each complete month after the date of death during which the pre-payment certificate would have remained valid,

and for the purposes of these calculations a complete month is a month beginning on the date of death and ending on the date immediately preceding that date in the following month.

(9) Where, during the period of 3 months following the month in respect of which a claim for a refund may be made under paragraph (6), a person with a pre-payment certificate valid for 12 months–

(a) becomes a person to whom any of the provisions of regulation 7(1)(b) to (f) applies; or

(b) becomes a person entitled to remission under regulation 3 of the Travelling Expenses and Remission of Charges Regulations,

an application for a refund may be made by or on behalf of that person in accordance with paragraphs (11) to (13).

    (10) The refund referred to in paragraph (9) shall be the amount which is the difference between the amount paid in respect of the pre-payment certificate valid for 12 months and the amount payable for a certificate valid for 4 months on the date that the sum prescribed was paid.

    (11) Applications under this regulation for refunds shall be made to the Health Board which either received the sum prescribed under this regulation or approved the pharmacist or doctor to grant pre-payment certificates and shall be accompanied by the certificate (where granted) and a declaration in support of the application and any refund shall be made in such manner and subject to such conditions as the Scottish Ministers may determine.

    (12) Subject to paragraph (13) an application for a refund shall be made where the person–

(a) dies, or becomes resident in hospital and thereafter dies, within 24 months of the date of death; or

(b) has a pre-payment certificate valid for 4 months and becomes a person–

within 4 months of the date of expiry of the pre-payment certificate; or

(c) has a pre-payment certificate valid for 12 months and becomes a person–

within 7 months of the date of expiry of the pre-payment certificate; or

(d) becomes resident in hospital and remains there until the expiry of a pre-payment certificate, within 3 months of the date of expiry.

    (13) Where an application under this regulation is made outside the time limits specified in paragraph (12) the Health Board shall accept the application if the Scottish Ministers are satisfied that the delay was for good cause.

Refunds
     9. —(1) Where a charge has been paid under these Regulations by or on behalf of a person who was at the time of payment eligible for exemption from that charge, a claim for a refund may be made by or on behalf of that person.

    (2) A claim under this regulation for a refund of charges shall be made on a form provided for the purpose by the Scottish Ministers and shall be accompanied by the appropriate receipt and the appropriate declaration in support of the claim.

    (3) A claim under this regulation for a refund shall be made not less than one month but not more than 3 months after the date on which the charge was paid.

    (4) A claim under this regulation for a refund shall be made to the Health Board which received payment of the charge, and any refund shall be made in such manner and subject to such conditions as the Scottish Ministers may determine.

Revocations and savings
     10. —(1) The Regulations specified in column 1 of Schedule 4 are hereby revoked to the extent specified in column 3 of that Schedule.

    (2) Notwithstanding the provisions of paragraph (1), the provisions of the 2001 Regulations shall continue to apply on and after 1st April 2007–

(a) in respect of any drugs or appliances supplied prior to that date;

(b) in respect of any claims for refunds in respect of charges paid for drugs or appliances supplied prior to that date;

(c) in respect of any appliance listed in Schedule 3 where the examination or first examination leading to the supply of that appliance took place prior to that date.

(3) Notwithstanding the provisions of paragraph (1)–

(a) any exemption certificate issued by a Health Board under regulation 7 of the 2001 Regulations; and

(b) any pre-payment certificate issued by a Health Board under regulation 8 of the 2001 Regulations,

shall be valid for the purposes of these Regulations until the date of expiry of such certificates, as if such certificates had been issued under regulation 7 or regulation 8 respectively of these Regulations.

LEWIS MACDONALD
Authorised to sign by the Scottish Ministers

St Andrew's House, Edinburgh
6th March 2007

SCHEDULE 1Regulations 3, 4 and 5

CHARGES FOR ELASTIC HOSIERY

Column 1	Column 2
Appliance	Charge
Anklet, legging, knee-cap, below-knee or thigh stocking.	£6.85 each (ie £13.70 per pair)

SCHEDULE 2Regulation 5

CHARGES FOR TIGHTS

Column 1	Column 2
Appliance	Charge
Tights (per pair)	£13.70

SCHEDULE 3Regulation 6

CHARGES FOR FABRIC SUPPORTS AND WIGS

Column 1	Column 2
Appliance	Charge
Surgical Brassiere	£23.10
Abdominal or Spinal Support	£34.95
Stock Modacrylic Wig	£6.85
Partial Human Hair Wig	£150.75
Full Bespoke Human Hair Wig	£220.50

SCHEDULE 4Regulation 10

REVOCATIONS

Column 1	Column 2	Column 3
Regulations revoked	References	Extent of revocation
The National Health Service (Charges for Drugs and Appliances) (Scotland) Regulations 2001	S.S.I. 2001/430	The whole Regulations
The National Health Service (Charges for Drugs and Appliances) (Scotland) Amendment Regulations 2002	S.S.I. 2002/100	The whole Regulations
The National Health Service (Charges for Drugs and Appliances) (Scotland) Amendment Regulations 2003	S.S.I. 2003/130	The whole Regulations
The National Health Service (Charges for Drugs and Appliances) (Scotland) Amendment (No. 2) Regulations 2003	S.S.I. 2003/295	The whole Regulations
The National Health Service (Charges for Drugs and Appliances) (Scotland) Amendment Regulations 2004	S.S.I. 2004/66	The whole Regulations
The Primary Medical Services (Consequential and Ancillary Amendments) (Scotland) Order 2004	S.S.I. 2004/212	Regulation 10
The Health Act 1999 (Consequential Amendments) (Nursing and Midwifery) Order 2004	S.I. 2004/1771	Regulation 31
The National Health Service (Charges for Drugs and Appliances) (Scotland) Amendment Regulations 2005	S.S.I. 2005/124	The whole Regulations
The National Health Service (Charges for Drugs and Appliances) (Scotland) Amendment (No. 2) Regulations 2005	S.S.I. 2005/326	The whole Regulations
The National Health Service (Charges for Drugs and Appliances) (Scotland) Amendment (No. 3) Regulations 2005	S.S.I. 2005/617	The whole Regulations
The National Health Service (Charges for Drugs and Appliances) (Scotland) Amendment Regulations 2006	S.S.I. 2006/149	The whole Regulations
The National Health Service (Charges for Drugs and Appliances) (Scotland) Amendment (No. 2) Regulations 2006	S.S.I. 2006/246	The whole Regulations
The Pharmacists and Pharmacy Technicians Order 2007	S.I. 2007/289	Paragraph 27 of Schedule 1

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations consolidate the National Health Service (Charges for Drugs and Appliances) (Scotland) Regulations 2001 ("the 2001 Regulations").

The Regulations provide for the making and recovery of charges for drugs and appliances (other than dental or optical appliances) supplied under or by virtue of the National Health Service (Scotland) Act 1978 ("the Act").

Some changes have been made to the scheme operating under the 2001 Regulations as noted below.

In addition, the charges payable under the 2001 Regulations to 31st March 2007 are increased with effect from 1st April 2007 as follows–

The charge for drugs medicines and appliances (other than those specified in the Schedules) is increased from £6.65 to £6.85 (regulations 3(1)(b), 4(1)(b) and 5(1)(b));

The sum payable in respect of a pre-payment certificate is increased from £34.65 to £35.85 for a 4 month certificate, and from £95.30 to £98.70 for a 12 month certificate (regulation 8(4)).

The charges for elastic stockings is increased from £6.65 each to £6.85 each (from £13.30 to £13.70 per pair) (regulation 3(1)(a), 4(1)(a), 5(1)(a) and Schedule 1).

The charge for tights is increased from £13.30 to £13.70 (regulation 5(1)(a) and Schedule 2).

The charge for surgical brassieres is increased from £22.30 to £23.10 (regulation 6(1) and Schedule 3).

The charge for fabric supports is increased from £33.75 to £34.95 (regulation 6(1) and Schedule 3).

The charge for stock modacrylic wigs is increased from £6.65 to £6.85 (regulation 6(1) and Schedule 3).

The charge for partial human hair wigs is increased from £145.55 to £150.75 (regulation 6(1) and Schedule 3).

The charge for full human hair wigs is increased from £212.85 to £220.50 (regulation 6(1) and Schedule 3).

Regulation 1 provides that the Regulations shall come into force on 1st April 2007.

Regulation 2 defines the meaning of terms used in the Regulations.

In the definition of "accepted disablement" the reference to the "Scottish Ministers" in the 2001 Regulations is replaced by a reference to the Secretary of State as the function referred to is not a function of Scottish Ministers.

The definition of "Board" has been replaced with a definition of "Health Board". References to "Board" have been replaced by "Health Board" throughout.

References to "NHS Trust" have been removed.

In the definition of "supplementary prescriber", paragraph (b) now refers to the Register of Pharmacists maintained under Article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007, in place of the Register of Pharmaceutical Chemists maintained under section 2(1) of the Pharmacy Act 1954, which is prospectively repealed from 30th March 2007 by the Pharmacists and Pharmacy Technicians Order 2007.

In the definition of "supply form" and “terms of service "pharmacist" has been substituted for "chemist". A pharmacist will fall within the definition of chemist but a "chemist" need not necessarily be a pharmacist.

New definitions have been added of–

Regulation 3 provides that chemists who provide pharmaceutical services to patients shall make and recover charges in respect of the supply of drugs and appliances except where a declaration of entitlement to exemption is completed in respect of a patient. The wording of paragraph (1) has been amended from that in the 2001 Regulations to make provision for declarations of entitlement where pharmaceutical services are ordered on an electronic prescription form. The wording of paragraphs (2) and (3) has been amended slightly from that in the 2001 Regulations to make the meaning clearer to the reader.

Regulation 4 provides that doctors who provide certain pharmaceutical services to patients shall make and recover charges in respect of the supply of drugs and appliances and are to remit the sum recovered in charges to the relevant Health Board. The wording of paragraphs (3), (4) and (5) has been amended slightly from that in the 2001 Regulations to make the meaning clearer to the reader.

Regulation 5 provides that a Health Board which supplies hospital out-patients with drugs or appliances shall make and recover charges in respect of drugs or appliances supplied to the out-patients. The wording has been amended from that in the 2001 Regulations to make the meaning clearer to the reader.

Regulation 6 provides that a Health Board shall make and recover a charge from a patient in respect of the supply of a fabric support or wig. The wording has been amended and simplified slightly from that in the 2001 Regulations.

Regulation 7 provides for exemptions from charges for certain patients including those under the age of 16 or those who have a listed medical condition, or where the patient has an exemption certificate. The wording of sub paragraphs (a)-(c) of regulation 7(1) has been amended slightly from that in the 2001 Regulations. The conditions specified in sub paragraphs (e)(iii)-(vii) are itemised as separate conditions, rather than being included as sub-categories of sub paragraph (e)(ii) (forms of hypoadrenalism), which is an error in the 2001 Regulations.

The reference in regulation 7(1)(g) of the 2001 Regulations to regulations having effect under or by virtue of section 69(2) of the Act is changed to a reference to regulation 8 (regulation 7(1)(g)).

The wording of regulation 7(2) has been amended from that in the 2001 Regulations to make provision for declarations of entitlement where pharmaceutical services are ordered on an electronic prescription form.

Other minor changes have been made to the wording of the other paragraphs of regulation 7 to make the meaning clearer to the reader.

Regulation 8 provides for pre-payment certificates in respect of charges for drugs and appliances and for the circumstances in which a claim for refund of the cost of a certificate can be made. The effect of the provisions is the same as the effect of the provisions of regulation 8 of the 2001 Regulations, but the wording has been amended to make the meaning clearer to the reader. In paragraph (4)(b) and paragraph (11) "pharmacists" has been substituted for "chemist" which is used in Regulation 8(1)(b) and (13) of the 2001 Regulations.

Regulation 9 enables a person who was eligible for exemption from charges at the time of payment to claim a refund of those charges. Such claims shall be made on a form provided for the

purpose and shall be accompanied by appropriate evidence in support of the claim. The claim form is available from Community Pharmacists. This regulation refers to "refunds" and not "repayments" as in the 2001 Regulations. Other minor charges have been made to the wording, and a new paragraph (4) has been inserted.

Regulation 10(1) revokes the regulations which have been consolidated by these Regulations.

Regulation 10(2) provides that certain provisions of the 2001 Regulations will continue to apply after 1st April 2007 for certain purposes.

Regulation 10(3) provides for the continuing validity of exemption and pre payment certificates issued under the 2001 Regulations.

Schedule 1 sets out the charges for elastic hosiery. The description of appliances has been amended from that in the 2001 Regulations.

Schedule 2 sets out the charges for tights.

Schedule 3 sets out the charges for fabric supports and wigs.

Schedule 4 lists the regulations revoked by these Regulations.