AMENDMENTS TO THE MEDICINES AND RELATED SUBSTANCES AMENDMENT BILL, 2008

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Line 11: insert after the word product, the words: "medical device or IVD"

Page 3.

Line 4: substitute the words "which contains a Scheduled substance" for the words "in respect of which medicinal claims are made"

Line 9: substitute the words "which contains a Scheduled substance" for the words "in respect of which medicinal claims are made"

Line 11: insert the following paragraphs before paragraph (f) and the existing paragraphs (f), (g) and (h) becoming paragraphs (i),( j) and (k) respectively:

(f) by the insertion after the definition of "interchangeable multi-source medicine" of the following definitions:

“In vitro diagnostic medical device” ('IVD') means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles";

(g) by the substitution for the following definition of the definition of "medical device"

“Medical device' means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:

a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

(i) diagnosis, prevention, monitoring, treatment or alleviation of disease,

(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury,

(iii) investigation, replacement, modification, or support of the anatomy

or of a physiological process.

(iv) supporting or sustaining life,

(v) control of conception,

(vi) disinfection of medical devices,

(vii) providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and

b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

(h) by the insertion after the definition of 'medical practitioner of the following definition:

“medicinal claims” means claims that a foodstuff or a cosmetic cures or heals a recognised medical condition or illness of a human body".

Line 14: delete the words "in respect of which medicinal claims are made".

Line 38: insert the following subsections after line 38:

(2) A person may not be appointed as the Chief Executive Authority if such person

(a) is an unrehabilitated insolvent;

(b) is mentally unfit; or

(c) has been convicted of an offence committed after the Constitution

of the Republic of South Africa, 1993 (Act No. 200 of 10993) took effect and sentenced to imprisonment without the option of a fine.

(3) The Chief Executive Officer may be removed from office for-

(a) serious misconduct;

(b) permanent incapacity; or

(c) engaging in any activity that is reasonably capable of undermining the integrity of the Authority.

Line 39: substitute (4) for (2)

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Line 1: substitute (5) for (3)

Line 4: substitute (6) for (4)

Line 9: substitute (7) for (5)

Line 12: substitute (8) for (6)

Line 16: substitute (9) for (7) substitute the word "shall" for the word "may"

Lines 36 and39: insert after the word "product" the words "medical device or IVD”

Line 45: substitute the words "products, medical devices or IVDs” for the words "medicines, a cosmetic, a medical device or a foodstuff'

Lines 49 and 51: insert after the word "product" the words "medical device or IVD"

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Lines 4, 10, 13, 14, 39 and 41: insert after the word "product" the words "medical device or IVD"

Line 43: insert after the word "product" the words "medical device or IVD where practicable"

Line 48: insert after the word "necessary" the words "both within prescribed timeframes"

Line 49: insert after the word "product" the words "medical device or IVD"

Line 53: insert before the word "is" the words "in the case of a product"

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Line 5: insert after the word "shall" the words "within the prescribed timeframe"

Lines 7: insert after the word "product" the words "medical device or IVD"

Line 8: insert after the word "and" the words "if so requested by the applicant"

Line 11: insert after the word "product" the words "medical device or IVD"

Line 11: insert after the word "Minister", the following words: "shall within 30 days of receipt of the application from the Chief Executive Officer"

Line 12: insert after the word "product" the words "medical device or IVD"

Line 14: insert before the word "inform", the words: "shall within 30 days of receipt of the application from the Chief Executive Officer"

Line 15: insert after the word "accordingly" the words "and of the reasons for such disapproval"

Lines 16, 20, 22 and 25: insert after the word "product" the words: "medical device or IVD"

Line 32: delete the words: "certification and the"

Lines 33, 35 and 37: insert after the word "product" the words "medical device or IVD"

Line 40: insert after the word "section" the words "except for medical devices and IVD's"

Line 57: insert after the word "product" the words "medical device or IVD"

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Line 4: insert the following paragraph after line 4

“12) The Authority shall determine rules relating to the manner in which applications are considered including the timeframes for the consideration of such applications”

Lines 8, 10, 11, 23, 43: insert after the word "product" the words "medical device or IVD”

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Lines 10, 11, 14, 17, 25, 30, 32, 34, 41, 43, 44, 45, 46, 50, and 52: insert after the word "product" the words "medical device or IVD"

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Lines 9 and 17: insert after the word "product" the words "medical device or IVD"

Line 21: Substitute the following section for section 18A

"18A (1) No person shall supply any product, medical device or IVD according to a bonus system, rebate system or any other incentive scheme.

2) Notwithstanding subsection (1), the Minister may prescribe both acceptable and prohibited acts in relation to subsection (1),"

Line 26: Substitute the following section for section 188

"188 (1) No person shall sample any product medical devices or IVD.

(2) For the purposes of this section 'sample' means the free supply of.

products, medical devices or IVDs by a device or IVD establishment, manufacturer or wholesaler or its agent to a pharmacist, medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974 (Act No. 56 of 1974), or any professional or person authorized to use the device, but does not include the free supply of products for the purposes of clinical trials, medical device and IVD evaluations, donations of products to the state, tendering to the State and quality control by inspectors.

(3) Donations or use of products. medical devices or IVD's for exhibition purposes shall be as prescribed.

Line 39: substitute the word "shall" for the word "may"

Line 41 : insert after the word "product" the words "medical device or IVD"

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Lines 4, 7, 10, 14, 22, 27, 32, 37, 48, and 51: insert after the word "product" the words "medical device or IVD"

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Line 1: insert after the word "product" the words "medical device or IVD"

Line 1 0: insert after the word 'by" the following paragraphs:

(a) the substitution for the heading of the following heading:

“[Director-General] Authority to cause certain information to be furnished"

(b) the substitution for subsection (1) of the following subsection

Line 10: delete the words "the substitution for"

Line 11: delete the words "subsection (1) of the following subsection"

Lines 29 and 32: insert after the word "product" the words "medical device or IVD"

Line 44: Insert after line 44 the following paragraphs

(c) by the substitution in subsection (4) for paragraph (b) of the following paragraph:

(b) to any person apparently under the age of {14} 12 years except upon a prescription issued by an authorised prescriber and dispensed by a pharmacist, pharmacist intern or pharmacist's assistant or by a veterinarian or a person who is the holder of a licence as contemplated in section 22C (1) (a), or on a written order disclosing the purpose for which such substance is to be used and bears a signature known to the seller as the signature of a person known to such seller and who is apparently over the age of [14] 12 years; .

(d) by the substitution in subsection (6) for paragraph (e) of the following paragraph:

(e) in the case of a Schedule 2 substance, such substance may not be supplied to any person apparently under the age of [14] 12 years except upon a prescription issued by an authorised prescriber and dispensed by a pharmacist, pharmacist intern or pharmacist's assistant or by a veterinarian or a person who is the holder of a licence as contemplated in section 22C (1) (a), or on a written order disclosing the purpose for which such substance is to be used and bears a signature known to the seller as the signature of a person known to such seller and who is apparently over the age of [14] 12 years;

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Lines 3 and 8: insert after the word "product" the words "medical device and IVD"

Line 13: After line 13 insert the following paragraph:

(a) The Director-General may on application in the prescribed manner and on payment of the prescribed fee issue to a medical practitioner, dentist, [practitioner] nurse or other person registered under the Health Professions Act, 1974, a licence to compound and dispense medicines, on the prescribed conditions"

Line 14: substitute the letter (b) for the letter (a)

Lines 18 and 20: insert after the word "product" the words "medical device or IVD"

Line 24: substitute the letter (c) for the letter (b)

Line 25: substitute the following paragraph for the existing paragraph

(2) A licence referred to in subsection (1 )(a) shall not be issued unless the applicant has successfully completed a supplementary course determined by the South African Pharmacy Council after consultation with the Health Professions Council of South Africa, [the Allied Health Professions Council of South Africa] and the South African Nursing Council.

Line 30: substitute the letter (d) for the letter (c)

Line Line 36: substitute the letter (e) for the letter (d)

Line 40: substitute the letter (f) for the letter (e)

Line 43: insert after the word "product" the words "medical device or IVD”

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Line 33: insert after the word "products" the words "other than Schedule 0 substances"

Lines 43, 45, 50 and 52: insert after the word "product" the words "medical device or IVD"

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Lines 2, 5 and 8: insert after the word "product" the words "medical device or IVD"

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Lines 18, 19 and 20: delete the lines

Line 45 and 47: insert after the word "pharmacologists" the word "technicians",

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Lines 7, 11, 14, 19 and 27: insert after the word "product" the words "medical device or lVD"

Line 32: insert after the word "pharmacolosist" the word "technician".

Lines 36, 39,48 and 50: insert after the word "product" the words "medical device or IVD".

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Lines 6, 10, 18 and 25: insert after the word "product" the words "medical device or IVD"

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Line 26: substitute the following paragraph for paragraph (b)

(b) by the substitution in subsection (1) for subparagraph (xiii) of the following subparagraph:

to the responsibilities of both medical device and IVD establishments and users of medical devices and IVDs. in relation to the use. training maintenance calibration, post-marketing surveillance, sterilization, disinfection, recall disposal decomposition, decommissioning or decontamination of medical devices and IVDs"

Lines 32, 35, 47, 51, 54, 57 and 59: insert after the word "product" the words "medical devices and IVD"

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Lines 8, 13,14, 15, 16: 18: 19: insert after the word "product" the words "medical device or IVD"

Line 30: substitute the number "36(1)" for the number "36"

Line 33: insert after the word "product" the words "medical device or IVD"

Line 34: insert after line 34 the following paragraph:

(2). Notwithstanding subsection 1 the exclusion of an product medical device or IVD from the operation of section 22G shall be on the recommendation of the Pricing Committee.