STATUTORY INSTRUMENTS 2014 No. 29. - National Registration · STATUTORY INSTRUMENTS ... Additional…
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STATUTORY INSTRUMENTSSUPPLEMENT No. 8 28th March, 2014
STATUTORY INSTRUMENTS SUPPLEMENT
to The Uganda Gazette No. 18 Volume CVII dated 28th March, 2014
Printed by UPPC, Entebbe, by Order of the Government.
S T A T U T O R Y I N S T R U M E N T S
2014 No. 29.
THE NATIONAL DRUG POLICY AND AUTHORITY (REGISTRATION)REGULATIONS, 2014
ARRANGEMENT OF REGULATIONS
Regulation. PART IPRELIMINARY
PART IIREGISTRATION OF PRODUCTS
4. Registration of drugs, preparations, vaccines and other immunologicalproducts.
5. Register of drugs, preparations, vaccines and other immunologicalproducts.
6. Application for registration.7. Particulars and activities of manufacturer.8. Raw material specifications and details of their analytical methods.9. Manufacture of active raw material.
10. Requirements for sample of packaging. 11. Therapeutic effects and indications.12. Information leaflet.13. Registration of product manufactured outside Uganda.14. Certificate of registration. 15. Suspension or cancellation of certificate of registration.
Additional Requirements for Veterinary Drugs and Preparations
16. Additional requirements for veterinary drugs and preparations.17. Toxicity to animals, animal product consumers and handlers.18. Toxicity to the environment.
Additional Requirements for Herbal Medicine Products19. Application for registration.20. Specifications for the herbal medicine product.21. Good manufacturing practices not to apply to herbal medicine
products.22. Certificate of registration for herbal medicine products.23. Suspension of certificate of registration.
PART IIIREGISTRATION OF SURGICAL INSTRUMENTS24. Definitions.25. Registration of surgical instruments.26. Register of surgical instruments.27. Application for registration of surgical instruments.28. Surgical instruments deemed registered.29. Labeling requirements.30. Certificate of registration for surgical instrument.31. Suspension of certificate of registration. 32. Suspension for the health and safety of patients, users and other
persons.33. Reinstatement of registration of surgical instrument.34. Surgical instrument not to have adverse effects.35. Sale of surgical instrument to the general public.
PART IVGENERAL PROVISIONS RELATING TO REGISTRATION.36. Responsibility of applicant for accuracy of information submitted.37. Additional information and samples.38. Receipt and consideration of application by the Authority. 39. Application for amendment or alteration of registration. 40. Validity of registration. 41. Refusal to issue certificate of registration. 42. Application for renewal of registration. 43. Fees.44. Offences and penalties.
Schedule 1 Format for Register for Drugs and Preparation for Human orVeterinary Use and for Vaccines and Other ImmunologicalProducts
Schedule 2 Form 1 - Application for Registration of Human and VeterinaryDrugs and Preparations
Form 2 - Application Form for Registration of Vaccines and OtherImmunological Products for Human or Veterinary Use
Schedule 3 Form 3 - Certificate for Registration of Human or VeterinaryDrugs, Preparation and Vaccines or Other ImmunologicalProducts
Schedule 4 Form 4 - Application for Registration of Imported HerbalMedicine Products for Human Use
Form 5 - Application Form for Registration of Imported HerbalMedicine Products for Veterinary Use
Form 6 - Application Form for Registration of Local HerbalMedicine
Schedule 5 Format of Register for Surgical Instruments
Schedule 6 Form 7 - Application Form for the Registration of SurgicalInstruments
Schedule 7 Form 8 - Certificate for Registration of Surgical Instruments
S T A T U T O R Y I N S T R U M E N T S2014 No. 29.
The National Drug Policy And Authority (Registration)Regulations, 2014
(Made under Sections 35 and 64 of the National Drug Policy and AuthorityAct, Cap. 206)
IN EXERCISE of the powers conferred upon the Minister responsible for health bysection 64 of the National Drug Policy and Authority Act and on the advice ofthe National Drug Authority, these Regulations are made this 24th day ofMarch, 2014.
1. Title.These Regulations may be cited as the National Drug Policy and Authority(Registration) Regulations, 2014.
2. Application.These Regulations apply to the registration of
(a) human and veterinary drugs and preparations including herbalmedicine products for human and veterinary use;
(b) vaccines and other immunological products for human andveterinary use; and
(c) surgical instruments.
3. Interpretation.In these Regulations, unless the context otherwise requires
Act means the National Drug Policy and Authority Act, Cap. 206;
active ingredient means the antigenic substance or compound of anantigenic substance that induce specific responses in humans andanimals against an infectious agent, its antigens or toxins;
active pharmaceutical ingredient means any component that providespharmacological activity or other direct effect in the diagnosis, cure,mitigation, treatment, or prevention of disease, or to affect thestructure or any function of the body of a human being or animals;
antigen means a substance that when introduced into the bodystimulates the production of an antibody and includes toxins,bacteria, foreign blood cells, and the cells of transplanted organs;
Authority means the National Drug Authority;
batch means a defined quantity of starting material, packaging material, orproduct processed in a single process or series of processes and in thecase of continuous manufacture, means a defined fraction of theproduction, characterised by its intended homogeneity and includes lot;
batch number means a distinctive combination of numbers or letterswhich specifically identifies a batch, on the labels, the batch recordsand the certificates of analysis of a manufactured product andincludes lot number;
bulk product means any product that completes all processing stagesincluding the final packaging;
commitment batch means the production batches of an activepharmaceutical ingredient or finished pharmaceutical product forwhich the stability studies are initiated or completed post-approvalthrough a commitment made in a regulatory application;
diagnostic antigen means a crude or purified fraction isolated from themicrobial culture and intended for in vitro detection of an existingspecific immune response or antibodies;
dosage form means the physical form in which a product is prepared foradministration to the recipient;
drug includes a herbal medicine product which is packaged forcommercial purposes;
generic product means a drug which has the same qualitative andquantitative composition in active substances and the samepharmaceutical form as the reference drug , and whosebioequivalence with the reference drug has been demonstrated byappropriate bioavailability studies;
herbal medicine product means a finished, labeled herbal medicineproduct that contain as active ingredients aerial or underground partsof plants, or other plant materials, or a combination of these, whetherin the crude state or as plant preparations and which may containconventional excipients in addition to the active ingredients and mayalso contain by tradition, natural organic or inorganic ingredientswhich are not of plant origin;
immunological product includes vaccines, immunoglobulins andantisera and in vitro diagnostic antigens;
indication means the intended use of the product;
in-process control means checks performed during production in orderto monitor and if necessary, to adjust the process to ensure that aproduct conforms to its specifications and includes the control of theenvironment or equipment;
licensed person means a person licensed under the Act;
manufacturer means a person licensed to manufacture drugs or activepharmaceutical ingredients;
manufacturing process means the transformation of starting materialsinto finished products including drug substances or pharmaceuticaldosage forms through a single operation or a sequence of operations;
master cell seed means a collection of aliquots of a preparation of cells,for use in the preparation of a product, distributed into containers ina single operation and processed together in a manner that ensuresuniformity and processed and stored in a manner that ensuresstability;
master formula means a document or set of documents specifying thestarting materials with their quantities and the packaging materials,together with a description of the procedures and precautions requiredto produce a specified quantity of a manufactured product as well as theprocessing instructions, including the in-process controls;
ongoing stability study means the study carried out by a manufactureron production batches according to a predetermined schedule inorder to monitor, confirm and extend the projected re-test period orshelf-life of the active pharmaceutical ingredient, or to confirm orextend the shelf-life of the finished pharmaceutical product;
patent holder means an owner of a patent for a particular productseeking to register the product;
pharmaceutical form means the form stating
(a) the presentation of a product including solution, suspension,eye drops, emulsion, ointment, suppository, tablet, capsule;
(b) in case of injections, the type of presentation including vial andampoule; and
(c) the dental cartridge and the type of content including powderfor reconstitution, solution, suspension, oily solution;
pharmaceutical product means any medicine intended for human useand a veterinary product administered to food-producing animals,presented in its finished dosage form or as a starting material for usein the dosage form;
primary batch means a batch of an active pharmaceutical ingredient orfinished pharmaceutical product used in a stability study, from whichstability data is submitted in an application for registration for thepurpose of establishing a re-test period or shelf-life;
product means a drug or preparation for human or veterinary use or avaccine or other immunological product;
production means all operations involved in the preparation of apharmaceutical product, from receipt of materials, throughprocessing and packaging, to completion of the product;
production batch means a batch of an active pharmaceutical ingredientor finished pharmaceutical product, manufactured at productionscale by using production equipment in a production facility asspecified in the application;
proprietary name means the trade or brand name which is unique to aparticular product and by which the product is generally identifiedand registered in the country of manufacture;
reprocessing means the reworking of all or part of a batch of a productof an unacceptable quality from a defined stage of production so thatits quality may be rendered acceptable by one or more additionaloperations;
shelf life means the time during which the quality of the productremains acceptable for its intended use, established based onstability studies;
starting material means any substance of a defined quality used in theproduction of a pharmaceutical product, but excluding packagingmaterials;
validation protocol means a document describing the activities to beperformed in a validation exercise;
validation report means a document in which the records, results andevaluation of a completed validation program and proposals for theimprovement of processes or equipment are assembled.
PART IIREGISTRATION OF PRODUCTS
4. Registration of drugs, preparations, vaccines and otherimmunological products.(1) All products shall be registered in Uganda before sale or distribution.
(2) A person who intends to manufacture, import or export a product shall,prior to the manufacture, importation or exportation of the product, apply to theAuthority for registration of the product.
5. Register of drugs, preparations, vaccines and other immunologicalproducts.
The Authority shall maintain a register of the drug or preparation, vaccine orother immunological products registered under these Regulations, in the formatspecified in Schedule 1 to these Regulations.
6. Application for registration.(1) An application for registration of a product shall be made to the
Authority in the prescribed Form 1 of Schedule 2 to these Regulations forhuman or veterinary drugs and preparations and Form 2 of Schedule 2 forvaccines and other immunological products.
(2) An application for registration of a product may be made by
(a) the patent holder;
(b) a licensed person;
(c) the manufacturer; or
(d) an agent authorised by the manufacturer or patent holder.
(3) The application shall state
(a) the name, physical address, email address, the telephone and faxnumber of the applicant;
(b) the proprietary name of the product;
(c) the approved generic name of the product;
(d) the particulars of the product;
(e) the strength of the product in per unit form such as mg, mL, IU/G orIU/M, where applicable;
(f) the indication of the intended use of the product;
(g) the description of the product;
(h) the packaging specifications specified in regulation 10;
(i) the studies undertaken in respect of the product, if any;
(j) the safety and efficacy properties of the product;
(k) the chemistry and pharmaceutical form and aspects of the product;
(l) the registration and licensing status of the product in other countriesincluding the country of manufacture;
(m) the particulars relating to the toxicology and pharmacology of theproduct; and
(n) any other information as may be determined by the Authority.
(4) The application shall be in writing, in the English language and shallin addition to the requirements referred to under subregulation (3) beaccompanied by
(a) two samples of the product;
(b) all the general and specific information and documents relating tothe product;
(c) a complete index to the various appendices; and
(d) the prescribed fees.
(5) Where the original documents required under subregulation (4) are ina language other than English, the original documents shall be presentedtogether with certified English translations.
(6) Where an applicant wishes to amend any part of a submittedapplication, the applicant shall pay the prescribed fees for each proposedamendment.
7. Particulars and activities of manufacturer.(1) Where the applicant is not the manufacturer of the product, the
applicant shall provide in relation to the manufacturer
(a) the name, physical address, email address, telephone and fax numberof the manufacturer; and
(b) a copy of the manufacturing licence.
(2) Where different activities of manufacturing are carried out at morethan one site, the applicant shall provide the particulars specified insubregulation (1) in respect of each site, clearly specifying the activity which iscarried out at each site.
(3) The applicant shall provide details of
(a) the procedures used at the various stages of manufacture in the formof a flow diagram accompanied by a list of the equipment used ateach stage; and
(b) the an...