Act No: CAP. 244
Act Title: PHARMACY AND POISONS
SUBSIDIARY LEGISLATION
Arrangement of Sections
THE POISONS LIST (CONFIRMATION) ORDER

ARRANGEMENT OF PARAGRAPHS

1.

Citation

2.

Poisons List confirmed

SCHEDULES

SCHEDULE [para. 2] —

POISONS LIST

THE PHARMACY AND POISONS (REGISTRATION OF DRUGS) RULES

ARRANGEMENT OF RULES

1.

Citation and commencement

2.

Interpretation

3.

Control of the manufacture, etc. of drugs

4.

Application for registration of drug

5.

Fees

6.

Issue of certificate of registration

7.

Duration, etc. of certificate of registration

8.

Suspension or revocation of certificate of registration

9.

Conditions for registration of a new drug

9A.

Register

10.

Inspection of premises

11.

Offences and penalties

SCHEDULES

FIRST SCHEDULE [r. 4.] —

FORMS

SECOND SCHEDULE [r. 5(2)(b), 9(1B)] —

FEES

THE PHARMACY AND POISONS RULES

ARRANGEMENT OF RULES

1.

Citation

2.

Interpretation

3.

Importation of drugs and Part I poison

3A.

Restriction on the importation or manufacture of specified drugs

4.

Exportation of drugs and poisons

5.

Exemptions

6.

Poisons to be supplied only upon prescription

7.

Restriction of sales by licensed sellers of Part II poisons

8.

Restriction of sales by person licensed to deal in poisons for mining, agricultural or horticultural purposes

9.

Labelling of containers

10.

Indication of character of poison

11.

Directions as to use

12.

Containers for poisons

13.

Safe custody of poisons

13A.

Pharmaceutical representative’s permit

14.

Special provisions with respect to hospitals

15.

Transport of poisons

16.

Manufacture of drugs

17.

Restriction on sale of mepacrine and bisulphate tablets

18.

The Poisons Book

19.

Fees

20.

Forms

21.

Preservation of books

SCHEDULES

SCHEDULE I [r. 5]

THE PHARMACY AND POISONS (PARALLEL IMPORTED MEDICINAL SUBSTANCES) RULES

ARRANGEMENT OF RULES

PART I – PRELIMINARY

1.

Citation

2.

Application

3.

Interpretation

PART II – CERTIFICATE OF PARALLEL IMPORTATION AND PARALLEL IMPORT LICENCE

4.

Qualification to parallel medicinal substances

5.

Application for a certificate of parallel importation

6.

Issuance of certificate of parallel importation

7.

Certificate of parallel importation not transferable

8.

Validity of certificate of parallel importation

9.

Rejection of an application for a certificate of parallel importation

10.

Application for renewal of certificate of parallel importation

11.

Application for parallel import licence

12.

Additional requirements by the Board

13.

Board inquiries in country of origin

14.

Issuance of licence

15.

Licence not transferable

16.

Validity of licence

17.

Rejection of an application for a parallel import licence

18.

General conditions of parallel import licence

19.

Application for renewal of a parallel import licence

20.

Revocation, variation and suspension of parallel import licence

21.

Suspension of use, sale, supply or offer for sale or supply of medicinal substance

22.

Recall of a medicinal substance from the market

PART III – INVENTORY OF PARALLEL IMPORTED MEDICINAL SUBSTANCE

23.

Inventory of parallel imported medicinal substances

24.

Record-keeping obligations

PART IV – PHARMACOVIGILANCE

25.

Pharmacovigilance issues

26.

Additional obligations

PART V – PRICING OF PARALLEL IMPORTED MEDICINAL SUBSTANCES

27.

Principles of pricing of parallel imported medicinal substances

28.

Pricing guidelines

PART VI – PACKAGING AND LABELLING OF PARALLEL IMPORTED MEDICINAL SUBSTANCES

29.

Labelling and packaging guidelines

PART VII – INSPECTIONS

30.

Places authorized officers may enter

31.

Powers of authorized officers

32.

Use of records

33.

Entry of dwelling place

34.

Magistrate court to issue warrant

35.

Use of force

36.

Certificate of analysis

37.

Assistance of an authorized officer

38.

Obstruction

39.

Seizure

40.

Order for restoration

41.

Rejection of an application for order of restoration

42.

Appeal

PART VIII – TRACING OF PARALLEL IMPORTED MEDICINAL SUBSTANCES

43.

Establishment of a tracing system

44.

Data matrix of medicinal substances

45.

Functions of the tracing system

46.

Duties of a licensee

47.

Batch recalls

PART IX – THE PARALLEL IMPORTATION APPEALS COMMITTEE

48.

The Appeals Committee

49.

Procedure of Appeals

PART X – MISCELLANEOUS PROVISIONS

50.

Transition

51.

Offences in connection with application of parallel import licence

52.

Provision of false or misleading information

53.

Failure to comply with urgent safety restrictions

54.

The offence of use, sale, supply, e.t.c of a suspended medicinal substance

55.

General offence of breach of provisions in these rules

SCHEDULES

FIRST SCHEDULE —

FORMS

SECOND SCHEDULE [r. 10(2(b), 19(2)(b)] —

FEES

THIRD SCHEDULE [r. 48(5)] —

CONDUCT OF PROCEEDINGS OF THE PARALLEL IMPORTATION APPEALS COMMITTEE

THE PHARMACY AND POISONS (PHARMACOVIGILANCE AND POST MARKET SURVEILLANCE) RULES

ARRANGEMENT OF RULES

PART I – PRELIMINARY

1.

Citation

2.

Application

3.

Interpretation

4.

Objects and purpose

PART II – THE NATIONAL PHARMACOVIGILANCE SYSTEM

5.

Establishment of the Centre

6.

Stakeholders under the system

7.

Roles and responsibilities of healthcare providers

8.

Responsibility of patients and members of the public

9.

Roles and responsibilities of public health programs

10.

Role of county governments

11.

Responsibilities of a marketing authorisation holders

12.

Qualified person for pharmacovigilance

13.

Investigations for adverse drug event

14.

Good pharmacovigilance practices

PART III – POST-MARKETING SURVEILLANCE SYSTEM

15.

Enforcement

16.

Sampling of medical products and health technologies

17.

Recalls and withdrawals

18.

Responsibilities of Market authorization holders

19.

Establishment of the Technical Working Group

20.

Manufacture of health product technologies

21.

Surveillance system

22.

Post-marketing surveillance approaches

23.

Roles of patients and the public

24.

Role of healthcare providers

25.

Role of market authorization holders

26.

Role of manufacturers

27.

The Quality Control Testing Laboratory

28.

Role of wholesale dealers

29.

Role of the central procurement agencies

30.

Role of the Board

31.

Rapid alert system

PART IV – GENERAL PROVISIONS

32.

Offences

33.

Pharmacovigilance Assessment and Inspections

34.

Safety studies

35.

International collaboration for pharmacovigilance activities

36.

Reliance

SCHEDULES

SCHEDULE [r. 33(3)] —

CERTIFICATE OF GOOD PHARMACOVIGILANCE PRACTICES

THE PHARMACY AND POISONS (CONDUCT OF CLINICAL TRIALS) RULES

ARRANGEMENT OF RULES

PART I – PRELIMINARY

1.

Citation

2.

Interpretation

3.

Scope of application

PART II – APPROVAL TO CONDUCT CLINICAL TRIAL

4.

Application for approval to conduct clinical trial

5.

Processing of applications to conduct clinical trials

6.

Expert advisory committees

PART III – INVESTIGATORS AND SPONSORS

7.

Principal investigators

8.

Responsibilities of sponsors

PART IV – CONDUCT OF CLINICAL TRIALS

9.

Adherence to protocols

10.

Child participants

11.

Informed written consent

12.

Safety reports

13.

Data and safety monitoring board

14.

Investigational health product

15.

Pharmacy at site for clinical trial

16.

Clinical trial laboratories

17.

Quality assurance

18.

Termination of clinical trials

PART V – MISCELLANEOUS

19.

Amendments to protocol

20.

Inspection of clinical trial sites

21.

Clinical trials involving traditional or alternative medicines

22.

Online registry for clinical trials

23.

Clinical trials in special circumstances

24.

Reliance and recognition

25.

Offences and penalties

SCHEDULES

FIRST SCHEDULE [r. 4 (3)(a)] —

FORM

SECOND SCHEDULE [r. 4 (3)(c)] —

FEES

THIRD SCHEDULE [r. 4 (3)(c)] —

LABELLING REQUIREMENTS

THE PHARMACY AND POISONS (PHARMACEUTICAL WASTE MANAGEMENT) RULES

ARRANGEMENT OF RULES

1.

Citation

2.

Interpretation

3.

Application of the Rules

4.

Pharmaceutical waste minimization

5.

Management of pharmaceutical waste

6.

Responsibility of waste generator

7.

Segregation of pharmaceutical waste

8.

Packaging of pharmaceutical waste

9.

Labeling of pharmaceutical waste

10.

Recording of pharmaceutical waste

11.

Handling and collection of pharmaceutical waste

12.

Storage of pharmaceutical waste

13.

Transportation of pharmaceutical waste

14.

Importation of pharmaceutical waste

15.

Export of pharmaceutical waste

16.

Pharmaceutical waste treatment and disposal methods

17.

Supervision of disposal of pharmaceutical waste

18.

Disposal under section 46

SCHEDULES

FIRST SCHEDULE [r. 16 (3)] —

MANNER OF DISPOSAL

SECOND SCHEDULE [r. 17(2), (3)]

THE PHARMACY AND POISONS (REGISTRATION OF HEALTH PRODUCTS AND TECHNOLOGIES) RULES

ARRANGEMENT OF RULES

PART I – PRELIMINARY

1.

Citation

2.

Interpretation

PART II – REGISTRATION OF HEALTH PRODUCTS AND TECHNOLOGIES

3.

Control of the manufacture, etc., of drugs

4.

Application for registration of health product or technology

5.

Processing of application for registration of health product or technology

6.

Register of health products and technologies

7.

Collaborative measures when processing application for registration

8.

Annual retention

9.

Renewal of certificate of registration

10.

Validity of certificates

11.

Withholding, Suspension, or revocation of certificate of registration

12.

Withdrawal of certificate of registration

PART III – MISCELLANEOUS

13.

Variation of information on health product or technology

14.

Registration during emergency

15.

Registration for compassionate use

16.

Authorisation of unregistered health product or technology

17.

Revocation of LN 147 of 1981

SCHEDULES

FIRST SCHEDULE [r. 4(1), 14(2)] —

APPLICATION FOR REGISTRATION OF HEALTH PRODUCT OR HEALTH TECHNOLOGY

SECOND SCHEDULE [r. 4(3)(l)), 8(3)(b), 14(4)(d), 15(4)(c), 16(5)(h)] —

FEES

THE PHARMACY AND POISONS (TRANSPORTATION OF PHARMACEUTICALS) RULES

ARRANGEMENT OF RULES

PART I – PRELIMINARY

1.

Citation

2.

Interpretation

3.

Objectives of the Rules

4.

Application

PART II – REQUIREMENTS FOR TRANSPORTATION OF PHARMACEUTICALS

5.

Transportation licence

6.

Enforcement

7.

Verification

8.

Security during transportation

PART III – CATEGORIES OF TRANSPORT

9.

Obligations of air transporters

10.

Obligations of sea transporters

11.

Obligations of road transporters

PART IV – SPECIFICATIONS

12.

Loading and receiving bays

13.

Transport and delivery

14.

Monitoring of storage conditions during transit

15.

Temperature controlled vehicles

16.

Calibration of vessels

17.

Insulated containers

18.

Contingency planning

19.

Record keeping

20.

Standard operating procedures

21.

Compliance

22.

Offences and penalties

SCHEDULES

SCHEDULE —

FORMS