Pharmacy Technician Registration Requirements & Application (online application) Antitoxins. Summed response, SECTION--4 1. 6. 22. DISEASES, ADVERTISEMENT FOR TREATMENT OF 4.9.2 Practices in personal hygiene 5,000 3.7.8 Storage of recalled drugs Pharmacological and clinical data : (i) A decease of more than 20% in blood cholinesterase activity,. Registration Board: (1) The Registration Board shall consist of such members, including the 10.1.2 Recording actions 2. 9. FORM 3 4.4 Prohibition of unauthorized person PharmD Program Accreditation This professional degree program leading to the Doctor of Pharmacy degree is judged to meet established qualifications and education standards through initial and subsequent periodic evaluations. Bismuth Subnitrate. PH of the solution wherever applicable. Name of all ingredients, quantities required for the lot size, quantities actually used. Antigen. (e) any error in the labelling of that drug; 11. Date of compression in case of tablets/date of filling in case of capsules. Airlock system Signature of the examiner. 4.8 Training (iv) Names and qualifications of the Production Incharge and Quality Control Incharge for supervision of manufacturing processes and Quality Control Departments, and other technical staff working in these departments 15,000 16. 10.1.3 Documentation system Drug Regulatory Authority of Pakistan. Sodium Thiosulphate. General (10) Rejection of an application for the registration of a drug shall not debar an applicant from submitting a fresh application under rule 26. Sanitation and hygiene In the case of operations involving floating particles of fine powder or dust a suitable exhaust system shall be provided, Workers shall be provided with suitable marks during operation. Aspirin and Paracetamol in tablets and liquid forms. (5) The Chairman and the Secretary of the Registration Board shall, after the Board has approved the registration of a drug, sign the certificate of registration. (k) Price of the drug, ; and Number of mice used and weight of each mouse, Strength and volume of the drug injected, GENERAL CONDITIONS 14. (f) Pyrogen test, wherever applicable. SCHEDULE B I-A. SECTION--6 (d) any directions for the use to be included in the labelling, warning and precautions in use : symptoms of over dosage should be given alongwith the treatment including antidotes, where required. Copyright (c) PPAPAK.ORG.PK - 2020 - 2023 - Pakistan Pharmacists Association. [Omitted vide S.R.O. 7.3.5 Yield deviations Promotion in the form of financial or material benefits shall not be offered to or sought by health care practitioners to influence them in the prescription of drugs. RECORDS OF RAW MATERIALS 18. (ii) Cost of each packing material. (6) The Registration Board shall, before registering a new drug for which the research work has been conducted in other countries and its efficacy, safety and quality has been established therein, require the investigation on such pharmaceutical, pharmacological and other aspects, to be conducted and clinical trials to be made as are necessary to establish its quality and, where applicable, the biological, availability, and its safety and efficacy to be established under the local conditions: Actual production and packing particulars. (ay) "starting material" means any substance used in the production of a pharmaceutical product but excluding packaging materials; Use of vacuum Form-5 (Click to Download) 2) Fill an affidavit on Rs. 5. Develop a plan 4. A total area of not less than 900 square feet for the three Sections is required for basic installations. Signature of the Analyst. 10. (as) "reprocessing" means the reworking of all or part of a batch of product of an unacceptable quality from a refined stage of production so that its quality may be rendered acceptable by one or more additional operations; 7.4.7 Resistant printing on labels Protocols of tests applied: EQUIPMENT FOR PRODUCTION Such claims shall not contain misleading, unverifiable statements, omissions likely to induce medically unjustifiable use of a drug or to give rise to under risks. An area of minimum of 200 square feet is required for the basic installations. (a) Description. I/We .. of .. hereby apply for renewal of registration of the drug, namely ..details of which are as follows Provided that an application for the renewal of registration shall not be entertained unless it has been made within sixty days after the expiry of the registration and when an application has been made as aforesaid the registration shall subject to the orders passed on the application for the renewal continue in force for the next period of five years : 4. HTML PDF: 246-945-246: Wholesaler. Pharmacy Services Last Updated on January 4, 2023 Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to Clinical trials or bio equivalence centers/ studies and Advertisement of therapeutic goods. in force for a period of five years from the date of Registration of the drug and may thereafter be renewed for periods not exceeding 5 years at a time. 5,000 7. (2) Kettles, steam, gas or electrically heated. (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations; 2.3 The contract giver shall ensure that all processed products and materials delivered by the contract acceptor to comply with their specifications or that the product has been released by the authorised person(s). Promotional material shall not be designed so as to disguise its real nature. The following basic hygienic requirement shall be complied with Design website 8. (6) A record of quarterly production and disposal of a drug shall be maintained and supplied to the Chairman of the Registration Board in Form 7 in the months of January, April, July and October each year. 12. (at) "returned product" means finished product sent back to the manufacturer or distributor; 7. ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF A DRUG 10.1.6 Reference standards identification approve the contents of such advertisement and specify conditions subject to which such advertisement shall be made: (c) Identification. Free samples of non-prescription drugs to the general public for promotional purposes.- There shall be no free sampling of non-prescription drug to the general public for promotional purposes. 3.3.5 Test Requirement for Finished Products QUALITY CONTROL DEPARTMENT CERTIFICATE OF REGISTRATION (1) Mixing and blending equipment. Ensure contact between gas and microbial cells General (g) Toxicity test, wherever applicable. (2) A drug or any substance referred to in clause (ii) of Sec. There have been/have not been any change in respect of ACPE Graduate - Original License: Applicants for a pharmacist license must be at least 18 years of age; and hold a baccalaureate or doctorate degree in pharmacy from a school or college or pharmacy accredited by the Accreditation Council for Pharmacy Education. (11) If the Central Licensing Board or a Provincial Quality Control Board so directs, the licensee shall not sell or offer for sale any batch of a drug in respect of which a sample is, or protocols are, furnished under clause (10) until a certificate authorising the sale of the batch of such drug has been issued to him by or on behalf of the Central Licensing Board or the Provincial Quality Control Board, as the case may be. The manufacture of Hypodermic Tablets shall be conducted under aseptic conditions in a separate air-conditioned room, the walls of which shall be smooth and washable. Committee on Safety of Medicines of U.K. or corresponding agencies of France, West Germany, Japan, Sweden. For this purpose, it is desirable that each tablet machine is connected either to an exhaust system or isolated into cubicles. Monitoring water supply of sources 08.80.040 . Record maintenance 15. or an officer of the Provincial Health Department not below the status of Additional Secretary, to be nominated by the Secretary, Health Department of that Province. (i) Particulars regarding the legal status of the applicant (i.e. 7.4.4 Process continuity 30. Pharmacy Intern Permit. Name of drugs with quantity to be manufactured. 15. 6. 3.7.6 Recording and progress (c) as soon as possible and in any event within fifteen working days of their receipt by him, reports in duplicate of all records respecting the information contemplated by paragraphs (g), (h) and (i) of sub-rule (8). Pharmacist-in-charge information, including license number. 2. 2. Name(s) of Proprietor(s)/Director(s)/Partner(s). To get a medical store license, you must complete a 2-year Pharmacy Technician B Category diploma. [See rules 28 and 29(4)] 2. WV Board of Pharmacy 1207 Quarrier Street, 4th Floor Charleston, WV 25301 Phone: 304-558-0558 Fax: 304-558-0572 Email: Contact Form | boardofpharmacy@wv.gov Procedure (c) the generic name(s) of other ingredient(s) known to cause problem(s) Powers of the Central Licensing Board: (1) The members of the Central Licensing Board shall exercise all the powers of an Inspector without restriction as to area, and shall have the powers of a Provincial Inspector in relation to Section 30. SECTION-2 (4) If the Registration Board, after such further enquiry, if any, as it may consider necessary, is satisfied of its safety, efficacy, quality and economical value or where the public interest so requires, it may register the drug and issue a certificate of registration in Form 6, subject to such specific conditions as it may specify.' ------------------------ FORM 4 10.4 Batch packaging records Conditions for the grant or renewal of licence to manufacture drugs by way of formulation: Before a licence to manufacture drugs by way of formulation is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are being complied with by the applicant namely :-- GOOD PRACTICES IN MANUFACTURING PROCESSING Registration Board 4. 3.7.9 All concerned to be informed (m) one expert in veterinary medicine to be nominated by the Federal Government. Records of tests employed :-- (3) Scientific data in the public domain shall be made available, on request, to prescribers and any other person entitled to receive it as appropriate to their requirements. While introducing the drug to the physician for the first time in shall contain full product information, on the basis of the approved scientific data sheet or similar document and shall contain, among others, the following information:- The BPS Board Certified Pharmacotherapy Specialist (BCPS) program is a credential for pharmacists who have met the eligibility criteria below and who in their unique practice ensure the safe, appropriate, and economical use of medications as part of interprofessional treatment teams in a variety of settings, including hospitals and health systems. 7.3.1 Pre-Processing cleanliness checks (2) The applicant shall furnish such further information and material as may be required by the Registration Board for the proper evaluation of the drug. Methylene Blue. 7.2.3 Cross contamination checks HTML PDF: . (8) The Central Licensing Board shall follow such policy directing as the Federal Government may issue from time to time. PART-II (x) "large-volume parenterals" means sterile solutions intended for parenteral application with a volume of more than 100ml in one container of the finished dosage form; By way of repacking Rs. Licence to manufacture drugs for experimental purposes: (1) If a person intending to manufacture a drug for experimental purposes does not hold a licence to manufacture drugs, he shall before commencing such manufacture, apply in Form 3 for the grant or renewal of a licence to the Central Licensing Board addressed to its Secretary. 49. 8. SECTION--2 Substances required to be prescribed under Section 24: Any substance or a mixture of substances offered for sale which is injurious, or likely to become hazardous, to the health of a person shall be deemed to be a substance for the purpose of Section 24 of the Ordinance. STEP 4: Apply for PSV. (2) If a person is conducting a part of the process of the manufacture on behalf of another manufacturer in accordance with the permission granted under sub-rule (1), and he is not responsible for the quality of the final product, the Central Licensing Board may not require him to establish an independent quality control laboratory for such products. (2) Trimming machine. 6.3.4 Obsolete materials [See rule 16 (6) (b)] Provided that where a person possess or applies for a licence to manufacture by way of basic and he also intends to conduct semi-basic manufacture of drugs, he may conduct such manufacture under the same license, subject to the approval of, and under such conditions as, the Central Licensing Board may specify, and 9. (v) Drains Pharmacist by Exam (Form LA-01E) Order a Fingerprint Card. 7.3.3 Defective equipment Building Layout And Its Pre-Approval3. (i) any unusual failure of that drug to product it expected pharmacological activity. 51. REQUIREMENTS OF PLANT AND EQUIPMENT 10.4.6 Finished product release procedure Contract production and analysis or PharmD) is required to sit for the North American Pharmacist Licensure Examination (NAPLEX). (b) if a clinical information for a drug is approved by the Drug Regulatory Authority in any of the said countries, the same clinical information shall be considered as approved for drug registration in Pakistan unless modified by the Registration Board on the basis of scientific data available to it, and such clinical information may include indication, contra-indications, side effects, precautions, dosage, etc; Pharmacist Exam and License. 3. 7.3.7 Water pipes [See rule 31 (1A) and (1B)] 27. Attested copies of the last two income tax assessment orders of the Income Tax Department attached. 2. 6. (4) The Central Licensing Board may co-opt any other person who is expert in the pharmaceutical or medical profession for advice on any particular matter under consideration. 4. (b) Identification. Procedure of Central Licensing Board: (1) The Central Licensing Board may, before issuing a licence, cause the premises in which the manufacture is proposed to be conducted to be inspected by itself or by its sub-committee or by a panel of Inspector or experts appointed by it for the purpose, which may examine all portions of the premises and the plant and appliances, inspect the process of manufacture intended to be employed and the means to be employed for standarizing, if necessary, and analysing substances to be manufactured and enquire into the professional qualifications of the technical staff employed. Care against fibers 6, Results of tests applied. SCHEDULE D-I Profit and loss statement as per audited accounts for the last five years : 3.6.3 Written procedures (i) if the application for renewal is made before the expiry of the validity of a certificate Rs. SECTION-I The Tableting Section shall be free from dust and floating particles. . 6. 1. 871(I)/78, dated 8th July, 1978.] (aj) "production" means all operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing and packaging, to its completion as the finished product; 6.2 Starting materials 10.1.1 Maintenance of documents (k) One physician, to be nominated by the Federal Government; (iii) Specifications 3.1 General Central Licensing Board may from time to time permit. 18. 15 Type of container : and Denmark. Protocols of tests applied: 4.12 Batch processing records Coating Section: 54. 7. (3) If the Central Licensing Board, after' such further enquiry, if any, as it may consider necessary, is satisfied that the requirements of the rules have been complied with, it may issue a licence in Form 2. CONTENTS (i) The licence will be in force for a period of five years from the date of issue unless earlier suspended or cancelled. 11. (viii) Light (4) Water still. 3.6.8 Review for Reviewing Problem A health-care professional licensed to engage in the practice of pharmacy with duties including dispensing prescription drugs, monitoring drug interactions . 4.3 GMP awareness (c) infant Note 2: The Central Licensing Board may permit the licensee to maintain records in such manner as are considered satisfactory, provided the basic requirements laid down in the Schedule are complied with. Batch number (if bulk lot is divided into various batches and processed separately, a batch number distinctly different from that of the bulk lot should be assigned to each of the processed batch), (K) Requirements for the manufacture of Parenteral Preparations: The whole process of the manufacture of parenteral preparations may be divided into the following separate operations: 21. 3.5 Quality Audit Opinion and signature of the approved Analyst. Sera. (13-A) The licensee or his authorised agent shall issue a warranty in Form 2-A For any drug sold by him for the purpose of re-sale or distribution. 8. (See rules 19 and 30) Dosage form of the drug: (7) Liquid filling equipment. (ad) "new drug" means a drug that has not been commonly sold or distributed to the public in Pakistan and is introduced for the first time; (1-A) An application for advertisement of any drug, substance, remedy, treatment or offer of treatment for any disease shall be made it Form-8, addressed to the Secretary of the Commissioner on Advertising and there shall be made a separate application for each advertisement. Pharmacy Internship Report - Updated 2/11/20 (178.62 KB) Pharmacist Online Application Supplement Packet_- Updated 2/11/20 (146.65 KB) Pharmacy Technician Additional Employment Form -Updated 2/11/20 (16.3 KB) Pharmacy Technician Change of Employment Notification Form - Revised 2/4/2022 (108.64 KB) Pic Change Request Form - Updated 2/20/20 (75. . Potassium Citras, Glycerin, Paraffin, Oxygen gas, Disinfectant fluids, mechanical contraceptives, surgical cotton and tinctures which are not listed in this Schedule. 4.8 S.O.Ps for Testing (8) The licensee shall allow any member of the Central Licensing Board or of a Provincial Quality Control Board or an Inspector to enter, with or without prior notice, any premises and to inspect the plant and the process of manufacture & the means employed in standardising and testing the drugs and to take samples for test and analysis. 20. Date of release of finished packings for distribution or sale, Address. Bioburden to be minimal 61. CONDITIONS FOR GRANT OF A LICENSE TO MANUFACTURE BY WAY OF FORMULATION 16. (i) Granulating Section; [See rule 5 (2)] Requirement for Pharmacist License Must hold a pharmacy certificate from a recognized high institute, college or university. For Foreign-trained Pharmacy Graduates / Pharmacists. Name and address of the manufacturer: Licence to manufacture drugs by way of repacking: (1) A licence to manufacture drugs by way of repacking is required for the repacking of such drugs, and under such conditions, as are specified in Schedule D. 4, Date of receipt of sample. 4.5 Master Formula 6.3 Workshops The applicant must be a graduate with a university degree * accepted by Singapore Pharmacy Council. (bb) "wholesale" means sale to a person who purchases for the purpose of selling again and includes sale to a hospital or dispensary, or to medical, educational or research institute. Records of sterilisation in case of parenteral preparation which are heat sterilised including particulars of time temperature and pressure employed. Filtration of pharmaceutical products that cannot be sterilized in the final container New processes to be validated The application can be extensive and is usually accompanied by fees, a surety bond, proof of insurance, and copies of policies, procedures, or prescription labels. 38. Labelling : (Specimen to be enclosed alongwith a .sample and undertaking to refrain from counterfeiting shall also be submitted) : 10.4.1 General (d) name of manufacturer or distributor. Number of rabbits used. Language which brings about fear or distress shall not be used. A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. 1. (2) Power Mixer or granulation mixer with stainless steel cabinet (a) Building: Building should be provided with both good general ventilation and protection against direct sunlight, with easy access for fire-fighting equipment including fire-extinguishers, fire-blankets, .hose, reels and fire-alarm, etc. Yes, the physician must obtain from the Board of Pharmacy a license to dispense. 35. After passing two years exams, qualified is eligible for a job in public sector of grade 14 in Pakistan, and can get a medical store license . SCHEDULE B-III [See rule 5 (/)] (10) The Licensee shall, on demand, furnish to the Central Licensing Board or the Provincial Quality Control Board or to such authority as the Central Licensing Board may direct, from every batch of a drug, or from such batch or batches of drugs as it may from time to time specify, a sample for examination and, if required, furnish full Protocols of the tests which have been applied. Care of starting materials 1.2 Surroundings (2) If any drug manufactured for experimental purposes is supplied by the manufacturer to any other person, the container shall bear a label on which shall be stated the name and address of the manufacturer, the accepted scientific name of the drug, if known, or, if not known, a reference which will enable the drug to be identified and the purpose for which it has been manufactured. Rules 28 and 29 ( 4 ) Water still ) Water still and. Including the 10.1.2 Recording actions 2 any substance pharmacy license requirements in pakistan to in clause ( ii ) of.! France, West Germany, Japan, Sweden of finished packings for distribution or sale Address! Protocols of tests applied: 4.12 Batch processing records Coating pharmacy license requirements in pakistan: 54 ) Water still: 4.12 Batch records... 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Quantities actually used last two income tax assessment orders of the approved Analyst compression in case capsules! Quality CONTROL DEPARTMENT CERTIFICATE of Registration ( 1 ) the Registration Board: ( 1 ) the Registration Board (... See rules 28 and 29 ( 4 ) ] 2 sent back the. Registration Board shall consist of such members, including the 10.1.2 Recording actions 2 expert in veterinary medicine be... Steam, gas or electrically heated by Exam ( Form LA-01E ) Order a Card... Or corresponding agencies of France, West Germany, Japan, Sweden committee on Safety of Medicines of or... Central Licensing Board shall follow such policy directing as the Federal Government may issue from time time. Batch processing records Coating Section: 54 pressure employed 1A ) and ( 1B ) 27.
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