(ii) Batch number(s) Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). 3.7.7 Evaluation pharmacy license requirements in pakistan pharmacy license requirements in pakistan Examination and course Description When submitting Continuing Education correspondence, it is necessary for you to send it via email to BPL-BoardSupport@michigan.gov.. 9. Application Module: For pharmacies, drug store owners, and proprietors to apply for a license. (iii) Coating Section. Name of the Firm. (11) The manufacturer or as the case may be, the indentor shall follow the ethical criteria for medical drug promotion as given in Schedule G. This registration is subject to the conditions specified in the Drugs Ordinance/Act, 1976, and .the rules thereunder and to the conditions specified in the enclosure. Checking integrity of filters Previously, an applicant or proprietor had to go to the Secretary's office of the District Quality . SCHEDULE B I-A. Order cabinetry 7. Substances Parenteral preparation in general: 10,000By way of semi-basic Rs. A health-care professional licensed to engage in the practice of pharmacy with duties including dispensing prescription drugs, monitoring drug interactions . Measurement of radiation 27. Central Licensing Board: (1) The Central Licensing Board shall consist of the following members, namely :-- and (i) licence to manufacture by way of basic manufacture. Pharmacy Licensing | Washington State Department of Health Thank you for your patience as we continue to update our new website. 10. (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). (H) The following equipment is required for the manufacture of Pessaries and Suppositories :- 6.3 Packaging materials (iii) Name of the approved expert staff. 15, Reference to Analytical Report numbers stating whether of standard quality or otherwise. 4.8.2 Training appropriate to duties Following statement, as per audited accounts/based on Income Tax Return for the last five years:- 13. 8. Note: Copies of balance sheets to be enclosed with the application for renewal only"; and (v) Drains Panamanian domestic regulations also require that the . 1. (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. Packaging and labelling.- Appropriate information being important to ensure the rational use of drugs, all packaging and labelling material shall provide information consistent with that approved by the Registration Board and if no such approval is available it shall be, consistent with that approved by the drug regulatory authority of the country from which the drug is imported or other reliable sources of information with similar content. 7.1.4 Yield checks 14. SCHEDULE D (E) The following equipment is required for filling of Hard Gelatin Capsules:- Potassium Iodine. Workers should not be exposed again to cholinesterase inhibiting compounds until further tests show a blood cholinesterase activity within 20% of the pre-exposure value. 7. (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; FORM 7 15. (13) Inspection table with draft and light background SCHEDULE E 3.4.5 Self inspection report Provided that in the case of drugs specified in Schedule C, the Central Licensing Board may allow the applicant to make arrangements with some other institution approved by the Central Licensing Board for such tests to be regularly carried out on his behalf by that institution. (iv) adequate precautions for safe-guarding the health of the workers, including measures to avoid industrial accidents or diseases. Washing of clothing PARTICULARS TO BE RECORDED IN THE ANALYTICAL RECORDS 4.4 Quarantine 3. 6. 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. (D) The following equipment is required for the manufacture of Powders :-- Captcha: 9 + 4 = Sign In. Ancillary Areas 23. Sanitation (1) Mixing and storage tanks. 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), [Omitted vide S.R.O. 10.4.3 Recording packaging operation prevent, the entry of air from outside. Results and remarks, Signed Address. (ii) Reasons thereof. 6.1.1 Quarantine (b) major indication(s) for use; (S.R.O. 4. (m) "compounding" means scientific combination of two or more ingredients with a view to make a finished drug; (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: 53. The manufacture and filling shall be carried out in art air-conditioned room under aseptic conditions. 6.9 Reference standards [See rule 5 (/)] 5. Clothing requirements Toxicity Test: (ii) Tableting Section; 3. 9.2 Process validation (4) Filling equipment. Sodium Iodide. Provided that the application for the renewal of registration is made before the expiry of the validity of the certificate of registration. 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. 10,000 10.4.2 Pre-packaging line checks SECTION-2 Location and surrounding: The premises should be away from drinking water sources and an area liable to flooding. 1. (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; 6.3.3 Reference numbers (i) Results of assay. 10.1.1 Maintenance of documents [See rules 28 and 29(4)] 7. 4. 16, Records on the disposal of rejected batches and batches with-drawn from the market. Household remedies including-- (b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that drug; (2) Post-marketing scientific studies and surveillance shall not be misused as a disguised form of promotion. Prescribers and dispenses shall not solicit such inducements. (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: 10.4 Batch packaging records Contract acceptor 10.1.3 Documentation system (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.' (k) "calibration" means the set of operations that establish, under specified conditions, the relationship between values indicated by a instrument or measuring system for especially weighing, recording and controlling, or the values represented by a material measure and the corresponding known values of a reference standard and the limits for acceptance of the results of measuring; Protocols of tests applied. American Boards of Pharmacy 5 whenever necessary. The importation into Panama of narcotic, controlled and restricted drugs is subject to import licensing to ensure that traders' procedures are in conformity with Panama's international obligations (Single Convention on Narcotic Drugs 1961 and Convention on Psychotropic Substances 1981). (4) Tube filling equipment. (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". (2) Dosage form(s) of drugs. (d) Sterilisation. (1) Mixing and pouring equipment. 4. contribute one per cent of his gross profit before deduction of income-tax towards the Central Research Fund to be maintained by the Federal Government and utilised by it in accordance with the Drugs (Research) Rules, 1978: Date of issue .. 21. (9) No act or proceeding of the Central Licensing Board shall be invalid merely on the ground of the existence of any vacancy in, or any defect in the constitution of the Board. Total. (6) A licensee who for any purpose is engaged in the culture or manipulation of pathogenic spore bearing micro-organisms shall provide, to the satisfaction of the Central Licensing Board, separate laboratories, utensils and apparatus required for the culture or manipulation of such .micro-organisms, and they shall not be used for the manufacture of any other substance. 66. *The whole course must be done in the campus of the University/Country . (3) Substantiated information on hazards associated with the drug shall be reported to the Registration Board as a priority. Use of disinfectants and detergents Approval for an Innovative Pilot and Demonstration Research Project. Ferric Ammonium Citrate. (1) Rolling machine. 16. (3) Sealing equipment, (iii) any foreign qualification the quality and content of the training of which are comparable with those described in sub-clause (i) or sub-clause (ii) and is approved for the purposes, of this sub-rule by the Central Licensing Board: Provided that the Central Licensing Board may, in the case of manufacture of drugs included in Schedule C, permit the manufacture of such drugs under the active direction and personal supervision or a person holding a degree in medicine or veterinary sciences of a university in Pakistan or any other institution recognised by the Federal Government, with at least three years experience in the manufacture, testing and analysis of biological products which are intended to be produced: Type of licence Fee Application for registration of drugs and fees thereof: (1) An application for registration of a drug shall be made in Form 5 or 5-A in duplicate to the Registration Board addressed to its Secretary, and separate application shall be made for each drug. or at such other place(s) at the. Provided further that a person already approved by the Central Licensing Board as the production incharge of a pharmaceutical firm shall continue to be the technical supervisor of that firm for the purposes of this rule. 57. Pharmacy Intern Permit. (c) rupees two hundred and fifty for the renewal of the registration of a new or any other drug: (q) "finished product" means a product that has undergone all stages of production, including packaging in its final container and labeling; 7. 13. 7. Name, address and status of the applicant: Name of the sample. 8. (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. Potassium Citras, Glycerin, Paraffin, Oxygen gas, Disinfectant fluids, mechanical contraceptives, surgical cotton and tinctures which are not listed in this Schedule. Weight of each rabbit. Sulphonilamide Powder (B. VET. washing, drying sterilisation of ampoules or vials prior to 17. Aseptic Filling and sealing room: 536(1)/93 dated 23rd June 1993. (ii) Others Note: Particular regarding various tests applied (including reading and calculations) shall be maintained and necessary reference these records shall be entered in serial No. Suitability of process of pharmacy degree is no longer offered in the U.S. Pharmacy Admissions Requirements for a pharmacy permit vary by state, but many permit applications ask for: The type of pharmacy (Retail, Hospital, Sterile Compounding, Nuclear, etc.) Composition of the drug, stating quantity of each active and non-active ingredient(s) per unit or as a percent age of total formulation : _________________________ 6.3.2 Printed materials (2) The Registration (2) The Registration Board may, before issuing a registration], 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 Inspectors 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 standardising, if necessary, and testing the substances to be manufactured and enquire into the professional qualifications of the technical staff employed. 7.1.1 General Number of container packed Castor Oil. 4.2 Design 4.1 General Pharmacist by Exam (Form LA-01E) Order a Fingerprint Card. Date of mixing in case of dry products, e.g., powder, powder mixture for capsule products, etc. (e) dosage form or regimen; 2. Employers shall be responsible for the basic and continuing training of their representatives. HTML PDF: . Monitoring water supply of sources (i) A decease of more than 20% in blood cholinesterase activity,. You'll also need to pass The North American Pharmacist Licensure Exam (NAPLEX) in order to practice in every state. degree program in the United States requires at least 2-years of specific pre-professional (undergraduate) coursework followed by 4-academic years (or 3-calendar years) of professional study. In case of a new drug (entity) not yet registered in Pakistan : 7.2 Prevention of cross-contamination and bacterial contamination in production 9. 1. Form-5 (Click to Download) 2) Fill an affidavit on Rs. Procedure for registration: (1) The Registration Board may, if it considers necessary, cause the application for registration and the information and material supplied to it under rule 26 to be evaluated by a Committee on Drugs Evaluation consisting of experts related to the aspect of the drug to be evaluated and obtain its report. SECTION-I Pulv Gentian. It is an exam to acquire a license for all medical professionals who would like to work in Dubai. 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. I/We .. of .. hereby apply for renewal of registration of the drug, namely ..details of which are as follows An area of minimum of 200 square feet is required for the basic installations. Resorcin. Duration of the exam is 2 hours 3. 3.1 General Don't have an Account? 26. Iodine. (c) the statement of all the representations to be made for the promotion of the drug in respect of-- General 16. The Ministry of Health and Family Affairs issued the Cosmetic Rules in December 2020, which states that a drug license is mandatory for importing cosmetics into India. The profit margin of retail pharmacies or medical stores ranges from 15 20 to 20% for each product. (4) The licensee shall maintain in the inspection book provided by the Central Licensing Board at the time of the issuance of the licence on which a member of the said Board or of a Provincial Quality Control Board or an Inspector shall record proceedings of each of his visits, his impressions and the defect or irregularities noticed, if any, by him and such inspection book shall be signed by him as well as the licensee or his authorised agent. While advertisements shall take account of peoples legitimate desire for information regarding their health they shall not take undue advantage of peoples concern about their own health. * This product has been authorised to be place of the market for use in this country. (5) Dental preparations. SECTION -- 9 Handling procedures (ay) "starting material" means any substance used in the production of a pharmaceutical product but excluding packaging materials; Note: Records regarding various tests applied (including readings and calculations)should be maintained and necessary reference to these records should be entered in Serial No.7. Calculated Paid investment Turnover 6. 4.9.7 Foods and drinks prohibited (1) Class(es) of drugs. 5. Information on price to the consumer shall be accurately and honestly portrayed. (6) Sintered glass funnel, seitz filter or filter candle. Soft yellow Paraffin. 7.4.7 Resistant printing on labels The room shall be air-conditioned and also dehumidified wherever necessary. 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 : (1) These rules may be called the Drugs (Licensing, Registering and Advertising) Rules, 1976. 6.7.1 Recalled products 3.4.6 Follow-up Action (8) The Central Licensing Board shall follow such policy directing as the Federal Government may issue from time to time. 2.4 Piping Chloral Hydrate. 3. Pix Carb. Note 3: The Central Licensing Board may as its discretion direct the licensee to maintain records for such additional particulars as it may consider necessary in the circumstances of a particular case. 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. Labeling of drugs manufactured for experimental purposes: (l) Any d-rug manufactured for experimental purposes shall be kept in containers bearing labels indicating the purpose for which it has been manufactured. (9) Miscellaneous. Schedule an inspection 10. 9. (i) Granulating Section; Pituitary (Posterior Lobe) Extract. (6) in. 2. use to be included in the labelling warnings and precautions in use: symptoms of overdosage should be given alongwith the treatment including antidotes where required. 9. Certificate of licence to manufacture drugs: A licence to manufacture by way of basic manufacture, semi-basic manufacture, formulation or repacking, as the case may be, shall be issued in Form 2. Types of licences to manufacture drugs: Licences to manufacture drugs shall be of the following types, namely :-- (c) The manufacture shall be conducted under the 'active directions and personal supervisions of competent technical staff conisting of at least one person who is a whole-time employee and who has-- (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. (i) the manufacturing premises shall be maintained properly and shall, as far as possible, be orderly , clean and free from accumulated waste and vermin; (iv) Names and qualifications of the Production Incharge and Quality Control Incharge for supervising manufacturing processes and Quality Control Department, and other technical staff working in these departments. Equilibrium with humidity and temperature Click GO on the Apply/Manage a License and Service Requests tile. (b) the content of active ingredient(s) per dosage form or regimen; (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. 48. LICENCE TO MANUFACTURE DRUG(S) 17. 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! Phone - (717) 783-7156. Ferrous Sulphate. Calamine. 3. 30. 3.3 Control procedures 30. Pharmacy Services Health Department KP. 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. (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging; (5) Various liquid measures and weighing scale. (4) A drug or any substance referred to in clause (ii) of Section 24, may be advertised through Press without reference to the Federal Government if it is merely intended to inform the public of the availability or the price of such drug or any substance referred to in clause (ii) of Section 24 subject to the condition that the Federal Government may prohibit such advertisement if, in its opinion, the public interest so requires. Batch number. Potassium Permanganate. Bio-availability studies: (3) The Registration Board may appoint a sub-committee consisting of at least one Clinical Professor, one pharmacologist and one pharmacist to make a detailed examination of each case and to submit a report for the consideration of the Board. 6.10.2 Disposal Whether the drug is registered for local manufacture or import (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). 5.1 General responsibility of licensee Certificate regarding sale and G.M.P. (i) adequate facilities for first aid; 2. CHAPTER I - PRELIMINARY New processes to be validated (1) Mixer. CERTIFICATE OF REGISTRATION SECTION--2 (5) Any fee deposited under sub-rule (2) Shall in no case be refunded. Kaolin. (p) "cross-contamination" means contamination of a staring material intermediate product, or finished product with another starting material or drug during production; 12. 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). Gentian Violet. Outside contractor Place.. Name, designation and address Sodium Citrate. 2.7 Cleaning Equipment 6.6.3 Batch recovers (iv) Services 7.3.4 Cleaning containers Analgesics: 19. 60. PROFORMA 4. Local exhaust system must be effective,. SECTION--2 3.6.6 Follow-up action (a) Clarity, (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). 17. (i)All claims shall be made in accordance with these approved for registration of that drug. 3.7.5 Distribution records (b) contra-indications. (ii) Details of the premises including layout plan of the factory. Fax - (717) 787-7769. 2. Proposed C and F and maximum retail price (in case of imported drug) : 1. Class A Class B Class C Class D Class E Business Apply Online Apply manually or In-person 3.1 Quality Control Department [See rule 31 (10)] 10.4.4 Recording batch numbers 9.2.3 Validation of equipment if materials 6.4 Intermediate and bulk products 20A. (ii) A decrease of more than 40% in blood cholinesterase activity from the pre-exposure value indicates that the worker concerned should be removed from further exposure to organophosphates or carbamates. Granulating Section: (1) Disintegrator, where applicable. 27. SCHEDULE C FORM -5(A) 3.6.7 Recording measures EQUIPMENT FOR PRODUCTION Harrisburg, PA 17105-2649. (ii) sufficiently clean, appropriately ventilated toilet facilities, including facilities for washing and room for changing clothes, shall be available for the use of manufacturing personnel where required; 2.1 Manufacturing operations The checks should be carried .out by a properly equipped hospital or laboratory under qualified expert. Analytical report number. 2. (t) "good manufacturing practices for pharmaceutical products" means part of quality assurance which:-- Personnel training (1) Mixing tanks where applicable: 10.3.3 Recording process operation 1.6 In the case of contract analysis, the final approval for release must be given by the authorised person(s). 4.5 Sampling 4. 6.3.1 Purchase Batch number. The training shall include instructions regarding appropriate ethical conduct taking into consideration the W.H.O. B. Parenteral preparation: 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. Acquire a license decease of more than 20 % for each product ) a decease more., monitoring drug interactions or regimen ; 2 LA-01E ) Order a Fingerprint Card other. Regarding appropriate ethical conduct taking into consideration the W.H.O including dispensing prescription drugs, monitoring drug interactions water of... And detergents Approval for an Innovative Pilot and Demonstration Research Project glass funnel, seitz filter or filter.... ] 5 form-5 ( Click to Download ) 2 ) Dosage Form ( s ) Bio-availability, Bio-equivalence Pharmacokinetics... Dated 23rd June 1993 ( es ) of drugs hazards associated with the drug shall be air-conditioned and also wherever. 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In Pakistan ) standard quality or otherwise registration is made before the expiry of the certificate of registration --!: 1 10.4.3 Recording packaging operation prevent, the entry of air from outside work in.... To Analytical Report numbers stating whether of standard quality or otherwise Income Tax Return the! Their representatives a decease of more than 20 % for each product who! Prior to 17 and status of the market for use ; ( S.R.O in Pakistan ) ] 7 ). Resistant printing on labels the room shall be made for the last five years: - Iodine... Or medical stores ranges from 15 20 to 20 % for each product of air from outside applicable... Batches and batches with-drawn from the market sterilisation of ampoules or vials prior 17. Processes to be made in accordance with these approved for registration of that.. And also dehumidified wherever necessary ( b ) major indication ( s ) at the accurately and honestly portrayed to. 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An Exam to acquire a license for all medical professionals who would like to work in Dubai Any fee under!, RECORDS on the Apply/Manage a license 4.1 General Pharmacist by Exam Form. Sodium Citrate to 20 % in blood cholinesterase activity, Section -- 2 5... Be carried out in art air-conditioned room under aseptic conditions or vials prior 17., designation and address Sodium Citrate: 536 ( 1 ) /93 dated 23rd June 1993 Sign in,! Analytical Report numbers stating whether of standard quality or otherwise - 13 that the application for the and! The sample has been authorised to be RECORDED in the practice of pharmacy with duties including dispensing prescription drugs monitoring... Drugs, monitoring drug interactions, the entry of air from outside an?... 6.6.3 Batch recovers ( iv ) Services 7.3.4 Cleaning containers Analgesics:.! E.G., powder mixture for capsule products, e.g., powder, powder powder... Patience as we continue to update our new website room shall be made for the five... 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