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The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 SCHEDULE 2 — PROCEDURAL PROVISIONS RELATING TO THE GRANT, RENEWAL, VARIATION, REVOCATION AND SUSPENSION OF TRADITIONAL HERBAL REGISTRATIONS

1–2121 provisions

PART 1 — INTERPRETATION AND APPLICATION

Interpretation

1

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Scope and application of this Schedule

2

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Scope and application of this Schedule

3

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4

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5

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6

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7

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PART 2 — PROCEDURES RELATING TO GRANT, RENEWAL, COMPULSORY VARIATION, REVOCATION OR SUSPENSION OF TRADITIONAL HERBAL REGISTRATIONS

Requirement to consult the appropriate committee

8

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Provisional opinion against traditional herbal registration

9

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Licensing authority’s decision after appropriate committee report

10

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Licensing authority proposals in other cases

11

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Right to be heard by a person appointed or to make further representations

12

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Cases where suspension is to have immediate effect

13

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Cases where suspension is to have immediate effect

14

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PART 3 — VARIATION OF TRADITIONAL HERBAL REGISTRATION ON APPLICATION OF HOLDER

Hearing before appropriate committee

15

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Licensing authority decision

16

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Right to be heard by a person appointed

17

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PART 4 — REFERRAL TO THE COMMITTEE FOR HERBAL MEDICINAL PRODUCTS IN ACCORDANCE WITH ARTICLE 16C(4) OF THE 2001 DIRECTIVE

Hearing before appropriate committee

18

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Licensing authority decision

19

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Right to be heard by a person appointed

20

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PART 5 — HEARING BEFORE PERSON APPOINTED

Hearing before person appointed

21

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Back to The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 — full text

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