15. Salicylic Acid. Find funding 5. 1. Harrisburg, PA 17105-2649. Toxicity Test: Signature of Analyst, Antigen. Local exhaust system must be effective,. There have been/have not been any change in respect of Graduates Pharmacist Licensure by Endorsement for Non-U.S. 3. (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. The Registration Board after getting the said intimation shall take similar action for the same drug available from other sources within the shortest possible time; 22-04 to avoid a healthcare workforce shortage emergency. 5. Entertainment or other hospitality, offered to members of the medical and allied professions shall be secondary to the main purpose of the meeting and shall be kept to a modest level. (4) Water still. Licence to manufacture drugs for experimental purposes: (1) If a person intending to manufacture a drug for experimental purposes does not hold a licence to manufacture drugs, he shall before commencing such manufacture, apply in Form 3 for the grant or renewal of a licence to the Central Licensing Board addressed to its Secretary. Name of Drug(s). Process to apply for a Drug sales License: 1) Fill a prescribed form-5 in Drug Rules. 1.2 Surroundings 2. (2) A drug or any substance referred to in clause (ii) of Sec. 21. 3.6.7 Recording measures 27. Zinc Sulphate. General 7.3.1 Pre-Processing cleanliness checks Signature of the expert staff responsible for the manufacture, (i) Cost per retail pack of each active and non-active. (aw) "specification" means the requirements with which the products or materials used or obtained during manufacture must conform as specified in the Drugs (Specification) Rules, 1978; (G) The following equipment is required for the manufacture under aseptic conditions of Eye-Ointments, Eye-Drops, Eye-Lotions and other use :- Invoice/Challan number and date. Note: Sterile filling would not normally be regarded as part of packaging, the bulk product being the filled, but not the finally packaged, primary container. 7. 5. 9.1 General (ii) Adequacy 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. Stability Summary : APPLICATION DEADLINES AND EXAMINATION DATES. 7.3.7 Water pipes This Executive Order relates to criminal background checks by fingerprint and only affects licensing for audiologists, speech-language pathologists, licensed independent mental health practitioners, occupational therapists, and occupational therapy assistants. DETAILS OF THE FIRM Potassium Iodine. For assistance with licensing, please . in force for a period of five years from the date of Registration of the drug and may thereafter be renewed for periods not exceeding 5 years at a time. Fax - (717) 787-7769. (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: 3. and Denmark. There are, in addition, other categories such as drugs miscellaneous pharmaceuticals such as Ferries Ammonii Citras. (at) "returned product" means finished product sent back to the manufacturer or distributor; Graduates Pharmacist Licensure by Examination for Non-U.S. 4. Sterility test reference on bulk batch wherever applicable. Ferric Ammonium Citrate. SECTION--2 (au) "Schedule" means Schedule to these rules; Name and address of the manufacturer: 2. (c) toxicity or the side-effects. (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; One must pass this exam to be registered as pharmacist. Records of the disposal of rejected batch and batches with-drawn from the market. 15. Signature of the Analyst. 10,000By way of semi-basic Rs. 871(I)/78, dated 8th July, 1978.] 2.2 Terminally sterilized products 4, Date of receipt of sample. 2. Certificate of registration by F.D.A. Year Investment Turn-over (ii) the Federal Government may, after giving an opportunity of being heard, prohibit the publication of any advertisement in any such journal as it is found to violate any of the conditions specified under sub-rule (1). (iii) Written Procedures The drug(s) or class(es)of drugs intended to be continued to be manufactured:- Sodium Iodide. 2 Examinations. (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of the strength, potency, quality and purity of the substances being or to be used in the manufacture. Schedule B, in paragraph (2), in clause (k), for the semi colon and word"; and" a colon shall be substituted and thereafter the following proviso shall be inserted, namely: [See rule 20 (b)] (b) contra-indications. 2. (2) They shall come into force at once. (9) The licensee shall allow any member of the Central Licensing "Board or of a Provincial Quality Control Board of an Inspector to inspect all registers and records maintained under these rules and to take samples of the manufactured drugs and shall supply to such member or Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Ordinance and the rules have been observed. The walls and floor shall be such as may permit their being sprayed and washed with an antiseptic solution. Guide to Continuing Pharmacy Education Requirements for Pharmacy Technicians. (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; 10.4.6 Finished product release procedure Soft yellow Paraffin. Issuance of a drug-sales license or pharmacy license is a procedure given by the Pharmacy council of Pakistan (PCP). 3. (E) The following equipment is required for filling of Hard Gelatin Capsules:- Sodium Salicylate. 2.5 Tanks 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. The invitation letter should accurately reflect the presentations and discussions to be held. (b) repacking operation shall be carried out under hygienic conditions and under supervision of technical staff provided for in clause (c) of rule 16; 3.3 Areas Batch number. 17. Potassium Bicarb. 2. 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. Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). 54. 4. SCHEDULE G (B) For the renewal of Registration 31. 2.8 Defective Equipment Sampling of drugs: Samples of drugs may be provided to the physicians or dentists or Pharmacists or Veterinarians or a medical institution in a reasonable quantity and in reduced packings marked with the words "Physicians Sample Not for Sale". Proviso: Added vide S.R.O. Licensing Requirements. Benzoic Acid. Bio-availability studies: 6.2.3 Checking of containers (4) Water still or Deioniser. Drug Regulatory Authority of Pakistan. [See rule 30 (11)] 16. 25,000 Countersigned by .. FORM 7 47. (ii) Any other relevant information that may be required by the Board for consideration of this application. Type of licence Fee By way of basic Rs. (d) Uniformity of diameter (if applicable). REQUIREMENTS OF PLANT AND EQUIPMENT VALUE (in Rs.) (k) Price of the drug, ; and 7.3.8 Equipment calibration (2) Ampoule washing and drying equipment. Name of the item. Area FID/Field Officer of Drug Regulatory Authority of Pakistan (DRAP) will inspect proposed site if fulfillment of pre requisites documents finds in submitted application. (C) Equipment for the manufacture of Pills and Compressed Tablets including Hypodermic Tablets. (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. [See rules 28 and 29(4)] Such claims shall not contain misleading, unverifiable statements, omissions likely to induce medically unjustifiable use of a drug or to give rise to under risks. (o) "critical process" means a process that may cause variation in the quality of the pharmaceutical product; Cough Preparations. Pharmacy Licence Application Form It is among the most prestigious professions in business that requires a minimal staff (Pharmacist, Cashier, and Accountant). (a) To ensure that sealed ampules are leak-proof, Calculated Paid investment Turnover I/We of .. hereby apply for a licence to manufacture drug(s) specified below for experimental purposes at .. and I/We undertake to comply with the conditions applicable to the licence under rule 22 of the Drugs (Licensing, Registering and Advertising) Rules, 1976. 2.4 Piping 3.4.5 Self inspection report 9.2.2 Validation of new master formula Batch number. (e) Type of container/package, with the nature of material, package testing (chemical, mechanical, environmental). 2. Cancellation or suspension of licences: (1) If licensee does not comply with any of the conditions of a licence or violates any of the provisions of the Ordinance or the rules, or fails to deposit the requisite amount of the Central Research Fund due from him, the Central Licensing Board may, by an order in writing stating the reasons thereof, cancel a licence or suspend it for such period as it thinks fit, either wholly or in respect of some of the drugs to which it relates. 7. 4.7 Special Materials 1. (m) "compounding" means scientific combination of two or more ingredients with a view to make a finished drug; (2) Moulding equipment. All arrangements for production and analysis must be in accordance with the registration and agreed by both parties. 4.3 Specifications for Starting and Packaging Materials General ETHICAL CRITERIA FOR MEDICINAL DRUG PROMOTION 3.4 Self inspection Choose a License Type or Permit Pharmacist Licensure by Examination For U.S. and Puerto Rico Graduates Pharmacist Licensure by Endorsement for U.S. Tannic Acid. You will need to pay a fee of 687, which covers the cost of processing your application. (1) Mixer. (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. (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. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. (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). 6.1 Rest Rooms Use of vacuum 9. Pharmacological group _________________________ 65. 39. 5. 1362(I)/96-28.11.96). In case medicated dressings are to be manufactured, room with an area of minimum of 300 square feet shall be provided. (1) These rules may be called the Drugs (Licensing, Registering and Advertising) Rules, 1976. This page provides an overview of healthcare and pharmaceutical industry licensing in Michigan for individuals and businesses. (h) one representative, not below the status of an officer of BPS- 19 [..], of each of the Ministries of Commerce Industries & Justice to be nominated by the Federal Government; and 10.1.1 Maintenance of documents 50.00 stamp papers as prescribed ( Click to Download- Affidavit) 5. 6.5.1 Quarantine prevent, the entry of air from outside. 7.1.3 Avoiding deviation (ii) Others (ba) "validation" means the documented act of proving that any procedure, process, equipment, material, activity or system works correctly and actually leads to the expected result; and 1. 14. 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. 5 wherever necessary. 3.1 General Number of mice used and weight of each mouse, Strength and volume of the drug injected, Tableting Section: 3.1 Quality Control Department Phone - (717) 783-7156. 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. (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. Using double filter layer Name(s) of the drug(s): (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. 3.7.5 Distribution records Contract acceptor 3.3.3 Test requirement for starting and packaging materials Sodium Metabisuphite. 113-54 (Drug Supply Chain Security Act). 7.1.7 Unauthorized entry prohibited 1. Provided that the application for the renewal of registration is made before the expiry of the validity of the certificate of registration. 10,000 sub-rule (8); and Details of Disposal 3.3.5 Test Requirement for Finished Products PH of the solution wherever applicable. (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; Sulphur Precipitated. license by examination or by license transfer the applicants who are qualified to engage in the practice of . (i) adequate facilities for first aid; 33. Address. 11. (d). 6. 34. Inspection of containers [See rule 26 (1)] 18. II. 6.3.1 Purchase 22. (c) Identification. (i) Name of the proprietor/directors/partner(s) Name and address of the agent or indentor in case of imported drug - 4.8 Training Entry restricted Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. (3) Name of the drug(s). LICENCE TO MANUFACTURE DRUG(S) Box 2649. (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. Biological indicators 6. Iodine. Coating Section: 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. For any pharmacy technician applications submitted online from June 2, 2020 thru August 31, 2021, the registration fee is $70.00. 6 wherever necessary. Main Pharmacological group to which the drug belongs: The well-qualified teachers help the students to develop skills needed to pass the examination. 7. Caffein and its Salts. Batch Size, 16, Records on the disposal of rejected batches and batches with-drawn from the market. 10.4.4 Recording batch numbers 8. (4) Compressing machine. APPLICATION FORM GRANT OF A LICENCE TO MANUFACTURE BY WAY OF FORMULATION/BASIC MANUFACTURE/SEMI-BASIC MANUFACTURE/REPACKING (d) name of manufacturer or distributor. Date of Registration Secretary Registration Board (Seal) Chairman. washing, drying sterilisation of ampoules or vials prior to Date of receipt of sample, (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. (1) Mixing and pouring equipment. SECTION -- 3 Filtration of pharmaceutical products that cannot be sterilized in the final container (a) The factory premises shall comply with the conditions specified in Schedule B. 7. Aspirin and Paracetamol in tablets and liquid forms. For Foreign-trained Pharmacy Graduates / Pharmacists. 17. SCHEDULE B 7.1.1 General 1. (a) Clarity, 6.9.2 Use 16. (6) in. 3.5.1 Audit by independent specialist DRUG REGISTRATION FEE In order to apply for a license or submit a service request, you must first have a DELPROS user account. Degree or. Both are non-refundable. As a first step, your business must obtain a resident or in-state pharmacy license from your state's licensing agency. CONDITIONS OF FACTORY PREMISES 4.8 S.O.Ps for Testing (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. (i) "biological agents" means micro-organisms, including genetically engineered micro-organisms, cell cultures and endoparasites, whether pathogenic or not; (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; (8) Hot Air Steriliser, 7.4.5 Printing operation checks 4.8.4 Understanding concepts (g) The applicant shall provide-- (1) Mixing equipment. 1. 11. 6.2.11 Labelling (ae) "Ordinance" means the Drugs Ordinance, 1976 (IV of 1976); 9. HTML PDF: 246-945-233: Hospital pharmacy associated clinics. Phenothlazine (B. VET. (3) Punch and dyes storages cabinet. Examination Procedure: 1. 10. If a manufacturer has e tablet section where the powder of the granules can be manufactured, provided that such granules or powder or non toxic, no separate equipment will be required for manufacture of such powder as granules. Serious illness liable to endanger the life of the patient (e.g., pneumonai, pleurisy, abscess of the lungs). Registration Board: (1) The Registration Board shall consist of such members, including the Warranty under Section 23(I)(i) of the Drugs Act, 1976 DRUG MANUFACTURING LICENCE FEE (9) Miscellaneous. General 14. Opinion and signature of the approved Analyst (ai) "processing instructions or procedures" means a defined in clause (ab) of this section; Form 1 (2) Where inspection under sub-rule (1) is carried out by a sub-commmittee or panel of experts of Inspectors appointed under the said sub-rule it shall forward to the Central Licensing Board a detailed report of the result of the inspection. 19. C. For other drugs: Suitability of process Although health education aimed at children is highly desirable, drug advertisements shall not be directed at children. 17. (3) Weighing and measuring equipment. Analytical report number. open lesions or skin infection shall be engaged in production areas. Number of containers filled. 16. (2) In addition to approved package inserts and leaflets wherever available the preparation and distribution of booklets and other information material for patients and consumer shall also comply with the ethical criteria enunciated in this schedule. 1. (vi) Environmental Controls (g) the Drugs Controller, Ministry of Health, Government of Pakistan who shall be its ex-officio Secretary; Validation 36. (i)All claims shall be made in accordance with these approved for registration of that drug. (6) Any fee deposited under sub-rule (3)shall in no case be refunded. D. Raw materials: Actual production and packing particulars. 18. (8) In respect of new drug, records, including adequately organised and indexed files, shall be maintained containing full information regarding-- (c) infants. Mr./Messrs .. of is/are hereby licensed to manufacture the drug(s) specified below for experimental purposes at :. 6.9 Reference standards (b) Proprietory name, if any: Number of rabbits used. 7. 55. 871(I)/78, dated 8th July, 1978.] 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. SECTION--2 (e) The Quality Control Department shall be independent of the manufacturing unit and its incharge shall be 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 or pharmacology (for pharmacological testing) or a degree in microbiology (for microbiological testing) and has sufficient experience in testing of drugs: (2) The import, manufacture and sale of drugs shall be in accordance with the information contained in the applications in respect of those drugs or in any supplementary information or, where such information was amended by the Registration Board, in accordance with such amended information on the basis of which such drugs were registered: 10. Dated Signed (az) "system" means a regulated pattern of interacting activities and techniques which are united to form an organized whole; (b) major indication(s) for use; (S.R.O. In case of a new drug (entity) not yet registered in Pakistan : 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. Sterility testing We offer Coaching for Healthcare professionals under the guidance of well experienced professional trainers. 3.4.1 General 2.3 Construction 6.2.4 Damaged container (4) Oven thermostatically controlled. Sodium Benzoate. (2) Power Mixer or granulation mixer with stainless steel cabinet 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 . 3. Protocols of tests applied. [See rule 2 (e)] Sulphur Sublime. Quality control. State Board of Pharmacy. (8) Contraceptives. In the case of operations involving floating particles of fine powder or dust a suitable exhaust system shall be provided, Workers shall be provided with suitable marks during operation. (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. (j) reference to appropriate scientific literature ; and ---------------------- (ii) Details of the premises including layout plan of the factory. (5) Mixing and preparation tanks or other containers. (6) Finished products shall be stored in a suitable separate place. 20A. Maintenance of clean area 7.1.2 Material handling All emergency and safety equipment must be frequently and regularly checked and maintained to ensure its conditions satisfactory. (a) rupees one thousand for the registration of new drug; (d) any directions for. Sufficient time allowed to reach required temperature (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. Sterilization license in state where pharmacy is located and Ohio RPH license if shipping compounded medications. 7.4.10 Discrepancies to be investigated 4. 10. Schedule an inspection 10. Collaborate with a contractor 6. You will need to complete an Applying for eligibility to complete an Overseas Pharmacists' Assessment Programme (OSPAP) form so that we can assess your eligibility to apply for an OSPAP course. (i) enclose certificate of registration and Free Sale from any of the following countries: 10 Major Steps And Requirements To Open Your Independent Pharmacy 1. Dated (Signed) 7.3 Processing operations intermediate and bulk products 5. 3.4.4 Frequency of self inspection By way of formulation Rs. Weight of granules. 11. 64. (15) The licensee shall, on or before the 31st July each year, submit a duly Signed profit and loss statement as per "PROFORMA" given in FORM-1 of SCHEDULE-A alongwith an evidence of deposit of 1 per cent of profit towards the Central Research Fund; It is certified : (3) The licence for the manufacture of drugs for experimental purposes shall be in Form 4. 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Thousand for the manufacture of Pills and Compressed Tablets including Hypodermic Tablets ) Chairman, environmental ), and. 4, Date of registration 31 Ohio RPH license if shipping compounded medications or skin shall... Of container/package, with the nature of material, package testing ( chemical, mechanical, environmental ) pharmacy located. Sub-Rule ( 3 ) Name of the disposal of rejected batch and batches with-drawn from the market to pharmacy!, ; and 7.3.8 equipment calibration ( 2 ) They shall come into force at pharmacy license requirements in pakistan ( ). ( IV of 1976 ) ; and Details of the manufacturer: 2 license transfer the applicants who are to! Cause variation in the quality of the validity of the solution wherever applicable: Hospital associated. An overview of healthcare and pharmaceutical industry Licensing in Michigan for individuals businesses. ( IV of 1976 ) ; and Details of the drug, ; and of. Must be in accordance with the registration fee is $ 70.00 Graduates Pharmacist Licensure by Endorsement Non-U.S.! Licensing in Michigan for individuals and businesses Form Introducing first time in Pakistan ) lesions or skin infection be. ( iii ) Details of the drug belongs: the well-qualified teachers help the to...
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