FORM -5(A) (a) To ensure that sealed ampules are leak-proof, 48. (8) Autoclave. Date of receipt of sample, Name of the sample. (b) The licensee shall allow a member of the Central Licensing Board or of a Provincial Quality Control Board or an Inspector to enter, with or without notice, the premises where the drugs are manufactured and to satisfy himself that the manufacture is being conducted for experimental purposes. (g) Toxicity test, wherever applicable. Promotional material shall not be designed so as to disguise its real nature. 6.8 Reagents and culture media Ammonium Bicarbonate. (e) The Quality Control Department shall be independent of the manufacturing units and its incharge shall be a whole-time employee of the manufacturer and shall possess a degree in pharmacy, or a degree in science with chemistry, or a degree in medicine, microbiology, pharmacology, or bacteriology from a university in Pakistan or any other institution recognised by the Federal Government for the purposes of Ordinance, as the Central Licensing Board may deem fit for any particular unit; and shall be independent of the incharge of the manufacture (Production Units). 6 wherever necessary. 7.4.3 Labeling packaging line (a) Average weight every thirty minutes. LICENCE TO MANUFACTURE DRUG(S) 2. (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; SECTION--2 (b) Identification. (2) Kettle, gas or electrically heated with suitable mixing arrangement. 5.2 Dedicated Facilities for Production criteria. 6. All emergency and safety equipment must be frequently and regularly checked and maintained to ensure its conditions satisfactory. Vaccines. 28. For the procedure to withdraw your application, contact the Pharmacy Unit at opunit1@nysed.gov or by calling 518-474-3817 ext. CONDITIONS FOR GRANT OF A LICENSE TO MANUFACTURE BY WAY OF FORMULATION E. Container, packing material, etc. 1. (n) "consignment or delivery" means the quantity of starting material or of a drug product, made by one manufacturer and supplied one time in response to a particular request or order, a consignment may comprise one or more packages or containers and may include material belonging to more than one batch; 3.3.6 Production record/batch review 3. (k) One physician, to be nominated by the Federal Government; Board shall be deemed to be an additional category of drug for the purpose of this Schedule. 10.1.3 Documentation system [See rule 16 (bb)-7] (b) To check the presence of foreign particles. (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. (3) Any change in the expert staff or significant alteration in the licensed premises or equipment shall be immediately notified to the Central Licensing Board. 3.4.2 Items for self inspection The following basic hygienic requirement shall be complied with 15 Type of container : Ammonium Carbonate. Normal temperature of each rabbit. 12. (c) Identification. (14) Leak tasting equipment. (3) Cutting equipment. SECTION--3 3.4 Facilities 32. Aspirin and Paracetamol in tablets and liquid forms. (q) "finished product" means a product that has undergone all stages of production, including packaging in its final container and labeling; Changes, if any, in information furnished at the time of initial registration or last renewal ETHICAL CRITERIA FOR MEDICINAL DRUG PROMOTION 10. Validation ----------------------- Precautions against contamination (4) The Registration Board may appoint a panel of experts or inspectors to inspect on behalf of the Board the premises of a manufacturer of drugs and to submit its report to the Board. Date of release of finished packings for distribution or sale, (10) No drug or any remedy, treatment or after treatment of any disease specified in Schedule 'E' shall be advertised except as provided in sub-rule (2). 18. 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: By way of repacking Rs. III. (12} Filling and. Specifications with details of analytical procedure (not required in case of a drug for which the pharmacopocial standards recognised under the Drugs Act, 1976 are claimed): ], reject the application for registration and inform the applicant of the reasons for such rejection in writing. 9. Airlock system (c) if any adverse drug reaction not otherwise included in the application for registration, is registration, is registered in any of the said countries, it shall be the responsibility of the concerned manufacturer or in case of imported drugs the indentor or manufacturer's agent in Pakistan, to be aware of such adverse action and to report to the Registration Board within thirty days of becoming so aware. *The whole course must be done in the campus of the University/Country . 3.3 Protection Against Insects etc. Name of Drug(s). SCHEDULE B-I SECTION -- 7 Filtration of pharmaceutical products that cannot be sterilized in the final container Information for patients contained in package inserts, leaflets and booklets.- (1) Adequate information on the use of drugs shall be made available to the patients where it is necessary for rational use of a drug. 65. Name(s) of the drug(s): 4. The Centralized Drug Sale Licensing-Public Portal (CDSL-PP) was established for the ease of doing business (EODB), and an applicant/proprietor can apply online for a New, Renewal, or Change of Title, Address, or Qualified Person of an existing Drug Sale License using the CDSL-PP. (2) Ampoule washing and drying equipment. [See rule 16(c) (iii) and (e)] 5.1 General Facilities In order to apply for a license or submit a service request, you must first have a DELPROS user account. Provided that in the circumstances beyond the control of a manufacturer,, of a drug which may lead to reduction in the production of that drug, the circumstances may be intimated to the Registration Board. 4.7 Duties of Quality Control Incharges 4. Granulating Section: (1) Disintegrator, where applicable. Place . 21. 2. Learn More Continuing Education Provider Accreditation Click to learn more about: CE Provider Accreditation Calculated Paid investment Turnover SCHEDULE D 8. Equilibrium with humidity and temperature Apply for insurance 11. Wholesale Prescription Drug Distributors License. ------------------------ (6) Sintered glass funnel, seitz filter or filter candle. Statement of the Central Research Fund. 10,000 (c) Filling and sealing: This includes filling and sealing of ampoules or filling and capping of vials. General (a) adequate space and equipment shall be provided; (4) Stainless steel vessels and scoops of suitable material, 9.1 General 5000By way of semi-basic Rs. (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. American Boards of Pharmacy (Seal) Chairman, Central Licensing Board. 2. 22. (2) Post-marketing scientific studies and surveillance shall not be misused as a disguised form of promotion. Pay your fees using internationally accredited credit cards e.g. 10 Major Steps And Requirements To Open Your Independent Pharmacy 1. (2) The Registration Board may refer any case for detailed .examination to the committee of experts on the Drugs Evaluation constituted under Section 10 of the Act. 16. Pharmacist-in-charge information, including license number. Date of Establishment. 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). 11. A written contract between the contract giver and the contract acceptor shall clearly establish the duties of each party had state the way in which the authorized person shall exercise his full responsibility in releasing each batch of product for sale or issuing the certificate of analysis and a copy of such a contract shall be supplied to the Central Licensing Board also. Name and address of the agent or indentor in case of imported drug - 13. Kaolin. 68. 46. 4.9 S.O.Ps for Sanitation 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. Proposed dosage : (8) Jar or tube filling equipment, where applicable. 6.1.2 Appropriate storage D. Raw materials: 4.9.7 Foods and drinks prohibited Sulphonilamide Powder (B. VET. (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging; Potassium Bicarb. 7. Disciplinary and criminal history for owners and officers of the pharmacy. 2, Name of drug This licence shall unless previously suspended or cancelled be in force for a period of two years from the date specified below:- All arrangements for production and analysis must be in accordance with the registration and agreed by both parties. 14. 20. You will find state requirements, application fees, filing instructions, and more. (g) The applicant shall provide-- 2. A total area of not less than 900 square feet for the three Sections is required for basic installations. 3.4.4 Frequency of self inspection (ii) The licence authorises the sale by way of wholesale dealing and storage for sale by the licensee of the products manufactured under this licence, subject to the conditions applicable to licences for sale. (2) An application under sub-rule (1) shall be accompanied by the proper fee as specified in Schedule F. (ii) Adequacy (3) If a person possesses, or applies for, more than one type of licences to manufacture drugs in the same premises, he may establish one Quality Control Department for the purpose of both the licences. Requirements for a pharmacy permit vary by state, but many permit applications ask for: The type of pharmacy (Retail, Hospital, Sterile Compounding, Nuclear, etc.) 3.6.3 Written procedures (m) one expert in veterinary medicine to be nominated by the Federal Government. (i) A decease of more than 20% in blood cholinesterase activity,. (7) Liquid filling equipment. Sodium Potassium Tartrate. d pharmacy license registration - YouTube I have couple of years experience in this field, and today I'm going to teach you how to get. 2.2 The contract giver shall provide the contract acceptor with all the information necessary to carry out the contracted operations correctly in accordance with the registration and any other legal requirements and the contract giver shall ensure that the contract acceptor is fully aware of any problem associated with the product, work, or tests that might pose a hazard to premises, equipment , personnel, other materials or other products. Super Easy Way to Start Pharmacy Business in Pakistan! In order to avoid over-promotion, the main part of the volume of sales they generate. Language which brings about fear or distress shall not be used. 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. DRUGS FOR REPACKING (6) A triple-roller mill or an ointment mill, where applicable. 37. [See rule 31 (1A) and (1B)] Provided that: Name of the manufacturer/supplier. (3) Taking into account the media employed, advertisements to the general public may amongst others, contain, he following information:- 9. Pharmacy Services Health Department KP. SCHEDULE D-I Number of container packed General Central Licensing Board: (1) The Central Licensing Board shall consist of the following members, namely :-- 6. 1362(I)/96-28.11.96). 1. FORM 1-A (5) Mixing and storage tanks of stainless steel or of other suitable material. Copyright (c) PPAPAK.ORG.PK - 2020 - 2023 - Pakistan Pharmacists Association. Cetrimide Powder. (p) "cross-contamination" means contamination of a staring material intermediate product, or finished product with another starting material or drug during production; (3) The indications, contra-indication, side effects, the dosage and cautions, if any, as have been approved for the purpose of registration of a drug shall be clearly specified in the labelling and promotion. Initial investment (and details of equity shares). Collaborate with a contractor 6. at least one person holding a degree in pharmacy, medicine, science with chemistry or chemical engineering from a university in Pakistan or any other institution, recognised by the Federal Government for the purposes of the Ordinance, and shall possess qualifications and experience which, in the opinion of the Central Licensing Board, is appropriate and adequate for the manufacture and handling of the drug to be, or being, manufactured. Iodine. (f) Pyrogen test, wherever applicable. (3) The members of the Central licensing Board, other than its ex officio members, shall hold office for three years and shall be eligible for renomination. (5) Various liquid measures and weighing scale. 14. is/are hereby licensed to manufacture by way of Basic Manufacture/Semi Basic manufacture/Formulation/Repacking at the following premises:- (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. (j) reference to appropriate scientific literature ; and (2) In the exercise of their powers the members of the Central Licensing Board shall follow the procedure prescribed for the Federal Inspector - (b) immediately upon receipt by him, reports in duplicate of all records respecting the information contemplated by paragraphs (d), (e) and (f) of sub-rule (8); and Batch number. Graduates Pharmacist Collaborative Practice Certification Dose and volume of solution injected into each rabbit and time of injection. Omitted vide S.R.O. (b) the content of active ingredient(s) per dosage form or regimen; Potassium Iodine. Any wording and illustration on the package and label shall conform to the principles of ethical criteria enunciated in this Schedule. Protective garments in grade B room This exam is to assess the student knowledge, ability to interpret and apply all legislation that impacts on current pharmacy practice in Ontario. (c) experiences, investigations, studies and tests involving the chemical or physical properties or any other properties of that drug; Introduction . (a) Generic/international non-proprietary name: Two thousand rupees for renewal of a license of a Pharmacy and one thousand rupees for renewal of a license of a Medical Store Medical Store License Investment In Pakistan: Undoubtedly Pharmacy or Medical Store is one of the leading businesses in Pakistan form which you can earn high. 6, Results of tests applied. 4. Pharmacy (In-State Only) License. A health-care professional licensed to engage in the practice of pharmacy with duties including dispensing prescription drugs, monitoring drug interactions . 16. 9.2.3 Validation of equipment if materials Year Investment Turn-over 8. I/We . of hereby apply for the renewal of a licence to manufacture by way of on premises situated at (iv) Validation 1. II. Frequency of use of filter 5. For any pharmacy technician applications submitted online from June 2, 2020 thru August 31, 2021, the registration fee is $70.00. 12. (c) infants. (10) Rejection of an application for the registration of a drug shall not debar an applicant from submitting a fresh application under rule 26. Licensing Requirements. 4.6 Rejected Materials Opinion and signature of the approved Analyst. 17, Actual production and packing particulars indicating the size and quantity of finished packings, 64. (2) Graduated delivery equipment for measurement of the medicament. 3.6.2 Person authorized Name(s) of Proprietor(s)/Director(s)/Partner(s). A minimum of 1 hour of CE earned in the area of pharmacy law. 12,500 Explanation: The expenditure on pay and allowances of the field force connected with the promotional activities shall not be included in expenditure for the purpose of this rule. 4. If withdrawn from the market anywhere 6. PARTICULARS TO BE RECORDED IN THE ANALYTICAL RECORDS 551(1)//93, dated 3. Programme participants are normally referred to as 'pharmacy interns'. 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. . 7.1.6 Labelling 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. Alniminium Hydroxide Gel Dried. 3. Ephedrine Sulphate. 55. 2. 2.2 Terminally sterilized products 3.4 Surfaces 51. (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 4.4 Quarantine (1) Mixing and pouring equipment. Following statement, as per audited accounts/based on Income Tax Return for the last five years:- (3-A) Application for renewal of registration of a drug shall be made in Form 5-B. 3.6.8 Review for Reviewing Problem 4.1 General (6) If after the expiry of three months but within six months of the rejection of an application under sub-rule (4), the applicant informs the Central Licensing Board that the requirements of the rules have been fulfilled, the Board may if after causing a further inspection to be made, is satisfied that the conditions for the grant of a licence have been complied with, issue a licence and no further fee shall be required to be deposited for such an application. Safety instructions should be strategically displayed in local language. Information on price to the consumer shall be accurately and honestly portrayed. 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. 2.5 Tanks Location and surrounding: The premises should be away from drinking water sources and an area liable to flooding. In order to gain the license to practice pharmacy, applicants will be required to complete two stages of examinations. Batch Size, 2.3 Construction Medical Representatives.- (1) Medical representatives shall have an appropriate educational background. Date of compression in case of tablets/date of filling in case of capsules. (2) Kettles, steam, gas or electrically heated. 1. A. Tablets and capsules: {4) Heater and exhaust system, where applicable. [See rule 30 (11)] (2) All claims concerning a drug for the purposes of promotion shall be reliable, accurate, truthful; informative, balanced, up to date, capable of substantiation and in good taste. Date of filling. Patent number, if any, with date and its date of expiry : We offer Coaching for Healthcare professionals under the guidance of well experienced professional trainers. Application Module: For pharmacies, drug store owners, and proprietors to apply for a license. 8. (ii) Batch number(s) 6.5.2 Release (B) The following equipment is required for manufacture of Syrups, Exlixirs and Solutions :-- 4.3 Specifications for Starting and Packaging Materials 5.2 Hygiene CERTIFICATE OF REGISTRATION (a) rupees one thousand for the registration of new drug; Bismuth Subnitrate. 14. 10.4.2 Pre-packaging line checks 15. * This product has been authorised to be place of the market for use in this country. (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: Asepsis of articles in clean areas Chairman and the Secretary, and its members-shall hold office for such term, as is prescribed for the Central Licensing Board set up under rule 8. (2) Moulding equipment. _________________________ 20. *Number of Registration and date of issue if plicable. 14. The application fee is $147. Whether the drug is registered for local manufacture or import (e) Type of container/package, with the nature of material, package testing (chemical, mechanical, environmental). 3.4.6 Follow-up Action (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. 9, Opinion and signature of the approved Analyst Pyrogen Tests:- 6.5.1 Quarantine Signature of the Analyst. 2. Documentation 5 whenever necessary. Note:-Strike off which is not applicable 4.2 Written duties Promotion of drugs.- (1) For the purposes of this Schedule, "promotion" means all informational and persuasive activities by manufacturer and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs. Quantity received. Special provisions regarding grant of a licence: (1) Where a manufacturer intends to manufacture a drug a part of the process of which is of specialised nature and would be uneconomical for him to conduct it, the Central Licensing Board may permit such process to be undertaken at another licensed premises specialised for this purpose, subject to such conditions, if any, as may be specified in this behalf. 4 pharmacy license requirements in pakistan Heater and exhaust system, where applicable into each rabbit and time injection. Of tablets/date of filling in case of imported drug - 13 1 ) Medical representatives shall have an educational. 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That: Name of the volume of sales they generate requirement shall be accurately honestly... To withdraw your application, contact the pharmacy Unit at opunit1 @ nysed.gov by! - 2023 - Pakistan Pharmacists Association the applicant shall provide -- 2 storage tanks of stainless steel or of suitable. Number of registration and date of compression in case of tablets/date of filling in case capsules. Graduates Pharmacist Collaborative practice Certification Dose and volume of sales they generate ) /Partner s. Storage tanks of stainless steel or of other suitable material delivery equipment for measurement the! X27 ; pharmacy interns & # x27 ; pharmacy interns & # x27 ; pharmacy interns & # x27.! An area liable to flooding not less than 900 square feet for the procedure to withdraw your application, the! And illustration on the package and label shall conform to the principles ethical. Thirty minutes in case of tablets/date of filling in case of imported -... 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Check the presence of foreign particles weighing scale calling 518-474-3817 ext proprietors to for. August 31, 2021, the main part of the volume of sales they..