pharmacy license requirements in pakistan 21 Nov pharmacy license requirements in pakistan

3.6.5 Investigations Licensing requirements for Michigan healthcare and pharmaceutical companies and individuals. 10. 3.3.3 Test requirement for starting and packaging materials 2. 7.3.4 Cleaning containers Batch number. Sulphonilamide Powder (B. VET. 7.1.6 Labelling 3.4.1 General Sulphur Precipitated. SECTION -- 5 Pituitary (Posterior Lobe) Extract. [See rule 21(I)] Sodium Bicarbonate. 27. (a) the Director-General Health, Government of Pakistan, who shall be its ex-officio Chairman; Date of release finished packings for distribution or sale. The room shall be further dehumidified if preparations containing antibiotics are manufactured. (3) Polishing pan, where applicable, 3.6.6 Follow-up action MATERIALS 9. 2 Examinations. 5. 3.3.7 Stability studies There should be no drains at all in plants and in warehouse. ETHICAL CRITERIA FOR MEDICINAL DRUG PROMOTION After the DHA have pre-evaluated your documents, they will send you an email that contains the link to have your Primary Source Verification done. 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: (c) toxicity or the side-effects. 13. Pharmacy (In-State Only) License. 18. 4.9.2 Practices in personal hygiene . 1,000 per advertisement. Zinc Oxide. 45.00 Initial Fee. 2. 3.7.2 Authorized procedures Filtration of pharmaceutical products that cannot be sterilized in the final container 12. (7) In case of an imported drug, the indenter or any other approved representative in Pakistan of the foreign firm shall ensure regular and adequate supply of tee drug in Pakistan. Fax - (717) 787-7769. pharmacist registration renewal process in india. (3-B) Any application under sub-rule (1) or sub-rule (3) shall be accompanied by the proper fee specified in Schedule F. 40. ST-PHARMACY@PA.GOV. 3.3 Protection Against Insects etc. 9. (i) adequate facilities for first aid; Name of the sample. Documentation Entry restricted (3) Where inspection under sub-rule (2) is carried out by a Sub-Committee or panel of experts or Inspectors appointed under the said sub-rule, it shall forward to the Registration Board a detailed report of ;he result of the inspection. SCHEDULE F 24. 34. Conditions for Advertising: (1) The Federal Government may, after seeking advice of the Committee on Advertising, allow the advertisement of a drug, or any substance or a remedy as specified in Schedule D-1 or a treatment or offer of a treatment for any disease. [See rule 5 (2)] (2) Moulding equipment. Sodium Bromide. Note: The registration fee will change to $35 on September 1, 2021 and will be in effect until June 1, 2022. (ii) licence to manufacture by way of semi-basic manufacture; For Foreign-trained Pharmacy Graduates / Pharmacists. 15,000 6.9.4 Storage (5) Various liquid measures and weighing scale. 3. (4) If the Central Licensing Board is not so satisfied, it shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence may be issued. 10.4.3 Recording packaging operation (a) Average weight every thirty minutes. or the director or manager of the firm or company by which, the drug will be manufactured. Name of the sample. Licence to Manufacture I/We . of hereby apply for the renewal of a licence to manufacture by way of on premises situated at (c) rupees two hundred and fifty for the renewal of the registration of a new or any other drug: Local exhaust system must be effective,. This sort of license may be found here. Among the list of the best college for b category in Thokar Lahore Campus: 0301-6979333 | Hujra Shah Muqeem Okara Campus: 0304-6979333 | Ellahabad Kasur Campus: 0305-6979333 | alquaidcollege@gmail.com (g) precautions, contra-indications and warnings; 7. The training shall include instructions regarding appropriate ethical conduct taking into consideration the W.H.O. (ak) "purity" means the degree to which other chemical or biological entities are present in any substance; Application fee for Advertisement. Date of mixing in case of dry products, e.g., powder, powder mixture for capsule products, etc. in the country of origin (in English and in Form 5 (c) : Box 2649. Precautions during cooling DRUG REGISTRATION FEE Whether the drug is registered for local manufacture or import 4.9 S.O.Ps for Sanitation Care after final cleaning of materials (8) Where it is necessary in the public interest so to do, the Registration Board may register a drug on its own motion without having received any application for registration. 7.4.6 Label verification (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product; PRACTICE OF PHARMACY AS A PROFESSION. (d) any directions for. 6.3 Packaging materials Cetrimide Powder. Note:-Strike off which is not applicable 2.1 General Provided that such variation shall be recorded in writing with reasons therefor and also communicated in writing to the manufacturer for his record, Free samples of prescription drugs for promotional purposes.- Free samples of drugs may be provided in modest quantities to prescribers, preferably on request. (4) Stainless steel vessels and scoops of suitable material, FORM -5(A) (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. 6.9.1 Testing prepared reference standard 1.4 There shall be a written contract covering the manufacture and or analysis arranged, under contract and any technical arrangements made in connection with it. (7) and Rs. I/We .. of .. hereby apply for renewal of registration of the drug, namely ..details of which are as follows 1. 25. A. Tablets and capsules: (11) Reminder publications for the medical, pharmaceutical and allied professions shall include the name of the drug and its exact composition, the price, the name and address of the manufacturer and a statement to the effect that "Full information is available on request". ENCLOSURE OF THE APPLICATION FOR REGISTRATION OF A DRUG Opinion and signature of the approved Analyst. 5. 4.8 S.O.Ps for Testing General (a) Description. (d) name of manufacturer or distributor. (bb) An applicant for registration of insecticides, pesticides and household disinfectants shall, in addition to the conditions specified in Schedule B and Schedule B-l, comply with the conditions specified in Schedule B-l, A. (af) "packaging" means all operations, including filling and labelling which a bulk drug has to undergo in order to become a finished product; (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 (6) in. 10. Sterilization by moist heat (6) No advertisement under this rule shall contain any direct or indirect comparison in any way with any other drug or substance or remedy for any disease for the purpose of attracting customers or with a view to discredit other such product. This licence shall, in addition to the conditions specified in the rules made under the Drugs Ordinance/Act, 1976, be subject to the following conditions namely:- 1.1 Responsibility of licensee for drugs fitness for use. (4) Compressing machine. (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; Ancillary Areas (c) the statement of all the representations to be made for the promotion of the drug in respect of-- The applicant must be a graduate with a university degree * accepted by Singapore Pharmacy Council. criteria. 4, Date of receipt of sample. (a) The generic name(s) of the active ingredient(s); (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. If the license you are reciprocating was obtained on or after June 22, 1976, and before May 12, 1986, minimum passing general average score of 70; or If the license you are reciprocating was obtained on or after May 12, 1986, minimum passing converted score of 75. c. Multistate Pharmacy Jurisprudence Exam (MPJE) - Pass with a minimum score of 75. (h) Any other teats. Simulation of aseptic operations validation (g) "batch numbering system" means a standard operating procedure describing the details of the batch numbering; Class A Class B Class C Class D Class E Business Apply Online Apply manually or In-person 7.1.4 Yield checks Form-7 License: This type of Drug sales license should be used for the sales of Medicines for Importers, Exporters, Indentors and Manufacturers. (1) Rolling machine. Investment Turnover Profit before tax Percentage 1% before tax for Central Research Fund percentage of Profit 10.4 Batch packaging records 3. B.S. Resorcin. Calcium Carbonate. (12) The manufacturer or, as the case may be, the indentor shall supply the information in relation to safety, efficacy, production, quality, or availability of the drugs as and when required by the Registration Board with a view to ensure safety, efficacy or quality of the drug. The application fee is $147. DG Drug Module: A separate control panel has been developed for the DG Drugs Department for their due . (iii) Cost of direct labour, 65. 6.4.1 Storage General Room: (4) A licensee whose licence has been cancelled or suspended may appeal to the Appellate Board within sixty days of the date of receipt of the decision of the Central Licensing Board by the licensee and until the Appellate Board has given its order, the licence shall remain cancelled or suspended, as the case may be. 3. Japan, USA and European Company Member countries. (E) The following equipment is required for filling of Hard Gelatin Capsules:- [See rule 20 (b)] SCHEDULE G Year Investment Turn-over Water supply Analytical report number. (e) Type of container/package, with the nature of material, package testing (chemical, mechanical, environmental). Sentonin. Control reference numbers in respect of raw materials used. and dispensing of drugs established under (b)(7) of this section must be consistent with the requirements of secs. (ii) the route of administration; (10) The chairman and the Secretary of the Central Licensing Board shall, after the Board has approved the issuance of a licence sign the licence. 51. Apply for a Pharmacy License / Pharmacy Pharmacy Pharmacy Exam Information Apply for a Pharmacy License Attention: If you are a military member or military spouse, please review our Military Resources page before applying. (11) Bacteriological filters such as Seitz filter, candles or sintered glass filters, (b) Wells: Walls as far as possible should be protected by non-flammable or slow burning material. Protocols of tests applied. (4) In the room provided for aseptic filling and sealing, necessary measures for maintaining sterility and to preventing contamination shall be adopted. sealing unit, 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 . 6.5.1 Quarantine 6.2.7 Identity of contents 3.1 The contract acceptor shall not pass to a third party any of the work entrusted to him or her under the contract without the written consent of the contract giver and prior evaluation and approval by the arrangements of the Central Licensing Board, and arrangements made between the contract acceptor and any third party shall ensure that the manufacturing and analytical information is made available in the same way as between the original contract giver and contract acceptor. 2. 145 (I)/76 dated 12th February 1976:- In exercise of the powers conferred by Section 41 of the Drugs Ordinance, 1976 (IV of 1976), the Federal Government is pleased to make the following rules, namely :-- Dated (Signed) I/We ..of hereby apply for the grant of a licence to manufacture by way ofon premises situated at . In order to become a licensed pharmacist, you must hold a Doctor of Pharmacy (Pharm.D.) Name of the sample. 2. The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. Ingredients : 8. Value of raw materials used (Active & inactive) (in Rs.) (ii) Others Name of Indenter/Manufacturer's agent/Importer (in case of imported drugs only). (vii) Packaging 5,000 10,000By way of semi-basic Rs. This registration shall be valid for a period of five years unless earlier suspended or cancelled. Name of the drug. By way of formulation Rs. (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. 4, Date of receipt of sample 5. 4.8.1 Written programme (v) high standard of personnel hygiene shall be observed by all persons concerned with production processes, and (f) one pharmaceutical chemist or expert in quality control, to be nominated by the Federal Government; Building Design And Construction (General) (iii) Details of the section-wise equipment and machinery for manufacture and quality control. Provided that: The word "safe" shall not be used with respect to promotion unless properly qualified. 21. FORM 2A 5. 10,000By way of semi-basic Rs. (e) "batch (or lot)" means a defined quantity of starting material, packaging material, or finish product processed in a single process or series of processes so that it could be expected to be homogeneous in the case of continuous manufacture the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity, and to complete certain stages of manufacture it may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to from a final homogeneous batch; Toxicity Test: Antigen. Asepsis of articles in clean areas 44. (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. 1. (ai) "processing instructions or procedures" means a defined in clause (ab) of this section; Name of the Firm. 1. (3) Weighing and measuring equipment. . Pharmacy exam: Questions will cover broadly most area of pharmacy, clinical, pharmacology, therapeutics, pharmacy calculations, over the counter medicines and patient counseling Glycerin. (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; Serious illness liable to endanger the life of the patient (e.g., pneumonai, pleurisy, abscess of the lungs). 5. 10.1.9 Packaging material specification (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. 41. 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. FEE FOR ADVERTISEMENT 3.4 Facilities Drug Regulatory Authority of Pakistan. 1. 6.2 Starting materials 1. 7.4.8 On-line packaging checks 2.4 Piping (au) "Schedule" means Schedule to these rules; 6.2.5 Delivery from different batches (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; (4) Oven thermostatically controlled. Care for biological indicators (d) "basic manufacture" means manufacture of a drug from basic raw material to a product which is ready for use as a starting material for the formulation of a finished drug or for repacking and such manufacture may involve chemical, bio-chemical, photochemical, microbial or such other processes or a combination of any of such processes; Additional conditions of licence to manufacture drugs by way of formulation: A licence to manufacture drugs by way of formulation shall, in addition to the conditions laid down in rule 19, be subject to the following further conditions, namely :-- Sec. ADDITIONAL CONDITIONS FOR MANUFACTURE OF STERILE PRODUCT (ii) Any other relevant information that may be required by the Board for consideration of this application. 10.4.10 Equipment utilization record (b) contra-indications. 6.4 Intermediate and bulk products By way of basic Rs. 7.1.1 General [See rule 31 (1A) and (1B)] Year Pharmacy Services Health Department KP. (4) Filling equipment. 2.3 Construction Protocols of tests applied: 47. An area of maximum 300 square feet is required for the basic installations. 4. The following basic hygienic requirement shall be complied with Signature of the Analyst. Sterility test as the last measures How to get a pharmacy license in Pakistan? Ephedrine Sulphate. 7. (10) Filling and sealing unit This room shall be air-conditioned. 43. Type of licence Fee Provided that under special circumstances to be recorded in writing, the Registration Board may register a drug and require such investigations and clinical trials to be conducted after its registration. Signature of the expert staff responsible for the manufacture, FOR EXPERIMENTAL PURPOSES Solution of serum proteins intended for injunction. (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. (2) Medical representatives shall make available to prescribers and dispensers complete and unbiased information for each product discussed, such as an approved scientific data or other source of information with similar contents. It is also certified that (a) the manufacturing plant in which the product is produced is subject in inspections at suitable intervals, and (b) the manufacturer conforms to requirements for good practices in the manufacture and quality control, in respect of products to be sold or distributed within the country of origin or to be exported. Sodium Chloride. 28. of Pack Total quantity in terms of individual units e.g., total No. Date of issue .. 16. Pennsylvania Licensure Requirements. 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. 2. 2, Name of drug 6.6.2 Reprocessing 6. APPLICATION FORM FOR RENEWAL OF REGISTRATION OF ALL KINDS OF DRUGS Super Easy Way to Start Pharmacy Business in Pakistan! (a) recommended clinical use and the claims to be made for the drug. 50. Contract production and analysis (8) The Central Licensing Board shall follow such policy directing as the Federal Government may issue from time to time. Name of the manufacturer/supplier. 7.1.8 In price controls Register Your Self. (iv) adequate precautions for safe-guarding the health of the workers, including measures to avoid industrial accidents or diseases. Have a desire to help 2. Monitoring water supply of sources 4.4 Prohibition of unauthorized person (4) Antidandruff preparations. (5) If any defects or irregularities are recorded in the inspection book under sub-rule (4) the manufacturer shall take steps to remove such defects or irregularities. 8. 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. Gripe Waters. (ax) "standard operating procedure" means an authorized written procedure indicating instructions for performing operations not necessarily specific to a given product or material but of a more general nature such as equipment operation, maintenance and cleaning validation, cleaning of premises and environmental control sampling and inspection, and certain standard operating procedures may be used to supplement product specific master and batch production documentation; Name(s) of Proprietor(s)/Director(s)/Partner(s). 1. (ii) Where the usual information on indications and dosage is provided, that advertisement material shall contain information on contra-indications, side effects and other necessary precautions as may be applicable. (9) The following information shall be supplied to the Registration Board-- 3.5.1 Audit by independent specialist Washing of clothing 2.1 Manufacturing operations Control reference numbers in respect of the lot of glass containers used for filling. B. Parenteral Preparations 3.4 Surfaces Phenothlazine (B. VET. and detailed records must be kept. 1.2 General.-- Contract production and analysis shall be correctly defined, agreed and controlled in order to avoid misunderstandings that could result in a drug or work or analysis of unsatisfactory quality. SCHEDULE B-II 6.6 Rejected and recovered materials Wholesale Prescription Drug Distributors License. (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. 3.3.5 Test Requirement for Finished Products 3. Magnesium Sulphate. Application fee $10.00: Pay by credit or debit card for applications submitted online. [See rule 26(3A)] To establish a pharmacy or medical store in Pakistan require grant of license by Secretary, District Health Authority. Date of receipt of sample, No. Staff must not be allowed to go home wearing the same clothing they wore at work; emergency showers and eye washing facilities must be provided in the premises. (i) (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. 18. A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. Date .. 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. "Levels of cholinesterase activity should be interpreted by a doctor, but the following guide might be helpful :-- Tableting Section: Don't have an Account? 4.7 Special Materials (vi) Environmental Controls 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. (j) One Surgeon, to be nominated by the Federal Government. An area of minimum of 250 square feet is required for the basic installation. 68. Design website 8. Certificate of registration by F.D.A. (4) A fee of rupees one hundred shall be paid for a duplicate copy of the licence if the original is defaced, damaged or lost. 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. 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. Comparison of products shall be factual, fair and capable of substantiation. (3) Reminder advertisements shall include, amongst others, at least the international non-proprietary name or generic name, the name of each active ingredient and the price of drug and the name and address for the manufacturer or distributor for the purpose of receiving further information. [See rule 26 (3)] 8. Renewal of a licence: On application being made for renewal, the Central Licensing Board may cause an inspection to be made, and if satisfied that the conditions of the licence and the rules are and will continue to be observed, shall issue a certificate of renewal or otherwise reject the application and inform the licencee accordingly. 4.8.5 Visitor and untrained personnel discouraged Proposed shelf life with storage conditions, if any : 08.80.040 . Licenses State Board of Pharmacy Permit Drug Enforcement Administration (DEA) Number National Provider Identifier (NPI) Number Duration of the exam is 2 hours 3. (l) "clean area" means an area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce and or eliminate introduction, generation and retention of contaminants within the area; (2) Coating pan. Opinion and signature of the approved Analyst. Sterility test reference on bulk batch wherever applicable. B. Parenteral preparation: (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. 3.2 Basic requirements 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. (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations; 4.3 Specifications for Starting and Packaging Materials (iii) Name of the approved expert staff. 5. (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). (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. Provided that the application for the renewal of registration is made before the expiry of the validity of the certificate of registration. 3.7.5 Distribution records Stability studies : (a) The licensee shall comply with the requirements and the conditions in respect of goods practices in the manufacture and quality control of drug; as specified in Schedule B-II. Medical Representatives.- (1) Medical representatives shall have an appropriate educational background. APPLICATION FORM GRANT OF A LICENCE TO MANUFACTURE BY WAY OF FORMULATION/BASIC MANUFACTURE/SEMI-BASIC MANUFACTURE/REPACKING

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