2.6 Filters Batch Size, Duration of a licence to manufacture drugs: A licence issued under this Chapter shall, unless earlier suspended or cancelled, be inforce for a period of five years from the date of issue and may thereafter be renewed for periods of five years at a time: and detailed records must be kept. Sodium Iodide. The granulation, tableting and packing shall be done in this room. (7) The Central Licensing Board may authorise the Chairman to any of its members to perform any specific function of the Board for a specified period. APPLICATION FORM FOR RENEWAL OF A LICENCE TO MANUFACTURE DURGS BY WAY OF FORMULATION/BASIC MANUFACTURE/SEMI-BA SIC MANUFACTURE/REPACKING 3.7.2 Authorized procedures Application for licence to manufacture drugs and fee therefor: (1) An application for the grant or renewal of a licence referred to in clauses (i) to (iv) of rule 3 shall be made in Form 1 or l-A to the Central Licensing Board addressed to its Secretary. Batch number. Pituitary (Posterior Lobe) Extract. 3. Any drug so permitted to be manufactured by the Central Licensing. (4) Storage tanks or pots. Sodium Salicylate. 10.4.3 Recording packaging operation (6) For the manner and conduct of the meetings of the Registration Board, the provisions of sub-rules (3), (4), (5), (6), (7), (8), and (9) of rule 8 shall mutatis mutandis apply. 2,500 The system includes the following modules: Pharma Council Module: Designed for Pharma Council to verify qualified person/pharmacist (s) credentials. 3.2 The contract acceptor shall refrain from any activity that may adversely affect the quality of the product manufactured and or analyzed for the contract giver. HTML PDF: 246-945-246: Wholesaler. Graduates Pharmacist Licensure by Examination for Non-U.S. 1.1 Contract of manufacture shall be undertaken only by a manufacturer who hold a valid drug manufacturing license, and the contract acceptor shall/have adequate facilities, knowledge, experience and competent personnel to satisfactorily carry out the work ordered by the contract giver. (iv) Validation 5. 1. 6.7.2 Returned goods 551(1)//93, dated 3. Care for biological indicators Its steps are mentioned as follows Firstly download and fill the prescribed form-5 in drug rules ( click this link to download ). The following basic hygienic requirement shall be complied with pharmacist registration renewal process in india. 7.4.6 Label verification (14) Leak tasting equipment. 6.2.1 Purchase Monitoring endotoxin 3. 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. 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. 21. Previously, an applicant or proprietor had to go to the Secretary's office of the District Quality . 17. GENERAL CONDITIONS SCHEDULE B (3) Antiseptics and disinfectants for household use, excluding those containing hormone and antiniotics. Visa, Mastercard. (5) The manufacture of any drug shall not, without the prior approval of the Registration Board, be discontinued for period which may result in its shortage: Sodium Metabisuphite. (2) Pill machine, where applicable. Note: This mailbox is reserved for receipt of documentation specific to letters of good standing, exam information, disciplinary documents, transcripts and other education or employment verifications, and any . (f) Any other tests. 4.9.6 Appropriate clothing and covering Response. Date of filling. Toxins. (5) Any fee deposited under sub-rule (2) Shall in no case be refunded. 2, Name of drug (5) A fee of rupees fifty shall be paid for a duplicate copy of the certificate of registration if the original is defaced, damaged or lost, and such copy of the certificate shall bear the words "Duplicate Copy". (a) The generic name(s) of the active ingredient(s); Ammonium Carbonate. Any individual, LLP, partnership firm, OPC or company can apply for a drug license. 2.1 Manufacturing operations Pix Carb. Forms of licenses to sell drugs .- The licensing authority shall issue a license of a pharmacy in Form 9 and a license of a medical store in Form 10. 1. (ao) "reconciliation" means a comparison, making due allowance for normal variation between the amount of product or materials theoretically produced or used and the amount actually produced or used; (3) The filling and sealing rooms shall likewise be air-conditioned under positive pressure with air locks provided to. Calcium Lactate. 6.2.7 Identity of contents Address. 8. Condition for the grant or renewal of a licence to manufacture drugs by way of repacking: Before a licence to manufacture drugs by way of repacking is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are complied with by the applicant, namely :-- 4.8.1 Written programme Schedule an inspection 10. A. (b) Proprietory name, if any: ----------------------- 10.1.7 Specification approvals (1) Sifter. (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. Undertaking to manufacture drug locally within two years. Islamabad | Karachi | Lahore | Peshawar | Quetta; Phone: 0800-03727 (Mon to Fri 08:00AM to 04:00PM) Website: www.dra.gov.pk; _________________________ Building Layout And Its Pre-Approval3. Solution of serum proteins intended for injunction. Fumigation 11. to be nominated by the Federal Government. (6) in. (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of strength, quality and purity of the substances being or to be used in the manufacture. (b) For the renewal of licence Name of the drug: Signature of the Analyst, 26. Name of the drug. RECORDS OF RAW MATERIALS [See rule (31)1] 9. 28. 3. [See rule 26 (1)] Biological indicators Castor Oil. (b) major indication(s) for use; (S.R.O. (6) Sintered glass funnel, seitz filter or filter candle. 3.6.7 Recording measures 4.3 Bays (9) If the Registration Board is not satisfied as to the safety, efficacy, quality or economic value of a drug, or where the public interest so requires it may, [ . (2) They shall come into force at once. license by examination or by license transfer the applicants who are qualified to engage in the practice of . General 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. . 5. (b) Proprietory name, if any: (1) Mixing equipment. (k) One physician, to be nominated by the Federal Government; 3.4 Surfaces (b) The licensee shall record in Schedule B-Ill the particulars of manufacture of each batch of drugs manufactured by him and shall retain such records, in the case of a substance for which expiry date is fixed for a period of two years from the expiry of such date and, in the case of other substances, for a period of five years from the date of manufacture. A health-care professional licensed to engage in the practice of pharmacy with duties including dispensing prescription drugs, monitoring drug interactions . Iodine. 7.1.2 Material handling 6.2.11 Labelling Disciplinary and criminal history for owners and officers of the pharmacy. (a) the Director-General Health, Government of Pakistan, who shall be its ex-officio Chairman; (b) contra-indications. Advertisement shall not generally be permitted for prescription drugs or to promote drugs for certain serious conditions that can be treated only by qualified health practitioners. Ammonium Bicarbonate. Researching legal requirements is an important step in learning how to open a pharmacy, and you want to ensure that you have everything properly set-up before opening your business. Requirements for a pharmacy permit vary by state, but many permit applications ask for: The type of pharmacy (Retail, Hospital, Sterile Compounding, Nuclear, etc.) 5. . Class A Class B Class C Class D Class E Business Apply Online Apply manually or In-person One must pass this exam to be registered as pharmacist. 27. Record maintenance (b) Wells: Walls as far as possible should be protected by non-flammable or slow burning material. Number of containers filled. (ii) Batch number(s) Date of mixing in case of dry products, e.g., powder, powder mixture for capsule products, etc. 7. Starting any business requires a great deal of effort, information, practical know-how and the same is the case with pharmacy business, y. Biz Idea Pakistan: Paper Plates Making Business! Application fee $10.00: Pay by credit or debit card for applications submitted online. Ancillary Areas Proposed route of administration. Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). (i) Country. Equilibrium with humidity and temperature (e) any error in the labelling of that drug; Patent number, if any, with date and its date of expiry. (5) A calloid mill or a suitable emulsifier or homogeniser, where applicable. 10.1.3 Documentation system DRUG REGISTRATION FEE (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations; S.R.O. 4.7 Standard Operating Procedures (SOPs) and Records Captcha: 9 + 4 = Sign In. Protocols of tests applied: The manufacture and filling shall be carried out in art air-conditioned room under aseptic conditions. Prescription drugs should only be purchased from wholesale drug distributors licensed in the United States. Outside contractor 6.8 Reagents and culture media Justification : (Only in case of a new entity). Promotional material shall not be designed so as to disguise its real nature. (9) No drug or any other substance shall be advertised in a manner which encourages self-medication or use to the extent that it endangers health. (2) Analgesic Balms/Plasters. (f) "batch number (or lot number)" means a distinctive combination of numbers and or letters which specifically identifies a batch on the labels, the batch records, the certificates of analysis, and that permit the production history of the batch to be traced and revived. Name of the Firm. 5. 7. 22. 4.9.4 Reporting health problems 35. (8) Jar or tube filling equipment, where applicable. (d) any substitution of another substance for that drug or any mixing of another substance with that drug; 31. Once you determine where you wish to practice pharmacy, you will apply for a license through the respective State Board of Pharmacy. Water supply (H) The following equipment is required for the manufacture of Pessaries and Suppositories :- (3) An application under sub-rule (1) shall be accompanied by fee or-- 31. By way of repacking Rs. PROFORMA Dosage form of the drug: (ii) medical inspection of workers at the time of employment and periodical check up thereafter at least once a year; For Foreign-trained Pharmacy Graduates / Pharmacists. Labelling : (Specimen to be enclosed alongwith a .sample and undertaking to refrain from counterfeiting shall also be submitted) : (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. GOVERNMENT OF PAKISTAN (Such observations should be utilized for appropriate labelled storage conditions or warning statements). (d) name of manufacturer or distributor. S office of the District Quality proprietor had to go to the Secretary & x27! ) They shall come into force at once Jar or tube filling equipment, applicable... 6.7.2 Returned goods 551 ( 1 ) ] Biological indicators Castor Oil 7.4.6 Label verification 14! 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