6.10 Waste materials approve the contents of such advertisement and specify conditions subject to which such advertisement shall be made: (ii) Tableting Section; 7. 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. Methyl Salicylate. (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; Date of Registration Secretary Registration Board (Seal) Chairman. Retailer's discount: The retailers discount shall be 15% of the maximum retail price. Phone - (717) 783-7156. 6.3 Packaging materials criteria. [See rule 7] GOVERNMENT OF PAKISTAN (f) the applicant shall ensure that-- 4.1 Capacity 6.2.6 Labelling APPLICATION FORM FOR RENEWAL OF REGISTRATION OF ALL KINDS OF DRUGS Provided that the conditions of location may be relaxed by the Board in suitable cases for grant or renewal or a licence subject to such conditions as it may deem fit, if the surroundings and the premises, in the opinion of the Board, are satisfactory for the intended manufacture. (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; 3.7.7 Evaluation APPLICATION FOR LlCENCE TO MANUFACTURE DRUG(S) FOR EXPERIMENTAL PURPOSES. Potassium Citras, Glycerin, Paraffin, Oxygen gas, Disinfectant fluids, mechanical contraceptives, surgical cotton and tinctures which are not listed in this Schedule. 1. (e) Type of container/package, with the nature of material, package testing (chemical, mechanical, environmental). Name and quantity of drug(s) to be manufactured for the said purposes:. 3.4.6 Follow-up Action Benzoic Acid. Safety instructions should be strategically displayed in local language. Name of the registered drug, with its registration number and date or initial ,registration and last renewal ' (y) "manufacture" means all operations of production, quality control, release, storage and the related controls; Provided further that the Central Licensing Board, may, in the case of anufacture of disinfectant fluids, insecticides liquid paraffin, medicinal gases, non-chemical contraceptives, plaster of paris, surgical dressing or chemicals for the manufacture of which the knowledge of pharmacy or pharmaceutical chemistry is not essential, permit manufacture of the drug under the active direction and personal supervision of competent staff who, [..] has in the opinion of the Central Licensing Board, adequate knowledge and experience in the manufacture of the drug (s) to be produced. Licensing Requirements. They shall be adequately trained so as to posses sufficient medical and technical knowledge and integrity to present information on products and carry out other promotional activities in an accurate and responsible manner. Name of the Company .Type of ownership (Partnership, Proprietorship, Public limited, Private limited, etc.) 7.4.11 Destruction of un-used packaging materials This licence permits the manufacture of (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations, the minimum space, plant and equipment for various operations are specified in Schedule B-1. 7. Sterility test reference on bulk batch wherever applicable. 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. (b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that drug; Registration Board (iv) Services C.). Universal Licensing Requirements. Note: Records racer, cling various tests applied (including reading and calculation) should be maintained and necessary reference to these records should .be entered in serial No. 6.1 Material, general 37. Provided that the Federal Government may, if in its opinion the public interest so required, withdraw the approval granted to any advertisement or modify or alter any condition subject to which the advertisement was approved. (v) high standard of personnel hygiene shall be observed by all persons concerned with production processes, and (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. (iv) licence to manufacture by way of repacking; and (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-- 10.3.3 Recording process operation (10) If a drug or any of its ingredients, which is imported or manufactured by a company in Pakistan is also approved for registration and free sale by its subsidiary, sister concern, associate or parent company in the country where it was originally developed or in any of the countries namely, USA, European Union Countries, Canada, Japan, Australia, and-- (2) Moulding equipment. Validation 3.4 Facilities By way of formulation Rs. (c) Any other tests 5. 2.2 Layout (15) Labelling and packing benches, Filed Officer will recommend or reject for establishment of pharmaceutical . 8. 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. 1. 2.4 Piping Opinion and signature of the approved Analyst The tanks or containers shall be made of either glass or such material which will not react with the liquid Main Pharmacological group to which the drug belongs: open lesions or skin infection shall be engaged in production areas. 4.8 Training (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 4.9 Personal hygiene An area of minimum of 300 square feet is required for basic packing operations. 6.3 Workshops 19. 18. 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 : Number of mice used and weight of each mouse, Strength and volume of the drug injected, Date .. 4.8.5 Visitor and untrained personnel discouraged (e) Testing, While introducing the drug to the physician for the first time in shall contain full product information, on the basis of the approved scientific data sheet or similar document and shall contain, among others, the following information:- (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". By way of repacking Rs. Sufficient water must be available for fire-fighting. 5,000 Class A Class B Class C Class D Class E Business Apply Online Apply manually or In-person Justification : (Only in case of a new entity). . (5) Any fee deposited under sub-rule (2) Shall in no case be refunded. 28. The bachelor's (B.S.) 4. 10.3 Batch processing records 3. 10,000By way of semi-basic Rs. 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. This license is not granted until before inspecting the premises and consequently issuing of inspection report after which the licensing authority shall issue a license for Pharmacy or Medical Store. (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. 4.8.2 Training appropriate to duties For any pharmacy technician applications submitted online from June 2, 2020 thru August 31, 2021, the registration fee is $70.00. (b) For the renewal of licence An area of minimum of 200 square feet is required for the basic installations. (5) A calloid mill or a suitable emulsifier or homogeniser, where applicable. 4.2 The contract shall specify the way in which the authorized person releasing the batch for sale ensures that each batch has been manufactured in, and checked for, compliance with the requirements of the marketing authorization. 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. HTML PDF: 246-945-235: Nonresident pharmacy license. (g) Toxicity test, wherever applicable. (7) The Central Licensing Board may authorise the Chairman to any of its members to perform any specific function of the Board for a specified period. (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. (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; 6. (2) Mixer. 10.1.10 Starting material re-assay We offer Coaching for Healthcare professionals under the guidance of well experienced professional trainers. (b) Identification. (6) in. CONTENTS Insulin. (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. In order to apply for a license or submit a service request, you must first have a DELPROS user account. (13) Inspection table with draft and light background Remarks. 6.2.10 Checking You will need to pay a fee of 687, which covers the cost of processing your application. 6.10.2 Disposal Pharmacy licensing. (a) The generic name(s) of the active ingredient(s); (i) Granulating Section; 14. Powers of Registration Board: The members of the Registration Board shall exercise all the powers of Inspector without restriction as the area, and shall have the powers of a Provincial Inspector in relation to Section 30. Yes, the physician must obtain from the Board of Pharmacy a license to dispense. 27. 3. Serial Number, Date of compression in case of tablets/date of filling in case of capsules. III. 8. Records of sterilisation in case of parenteral preparation which are heat sterilised including particulars of time temperature and pressure employed. About Us | Contact Us Search You & Your Family Community & Environment Licenses, Permits, & Certificates Data & Statistical Reports Emergencies For Public Health & Health Care Providers In this section Pharmacies General The applicant must be a graduate with a university degree * accepted by Singapore Pharmacy Council. Date Signed. 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. 3.4 Surfaces (225 ILCS 85/9) To add the STUDENT designation to your Pharmacy Technician license, you must submit: Proof of your status as a Student in an approved College of Pharmacy OR The word "safe" shall not be used with respect to promotion unless properly qualified. (I) The following equipment is required for the manufacture of inhalers end Vitrallae: (ah) "pharmaceutical product" means any drug intended for human use or veterinary use presented in its finished dosage form or as a starting material for use in such a dosage form; Sodium Thiosulphate. General Pharmacist Exam and License. 10.4.9 Equipment logbooks Care for biological indicators 8. (g) the Drugs Controller, Ministry of Health, Government of Pakistan who shall be its ex-officio Secretary; The fees for submitting your application include an application fee ($100) and an evaluation fee ($450). RECORDS OF RAW MATERIALS 10.4 Batch packaging records [See rules 28 and 29(4)] Contract production and analysis ----------------------- 19. 6.6.1 Storage and disposal 2. Actual production and packing particulars. The Doctor of Pharmacy (Pharm.D.) 5. It is compulsory to pass the DHA exam in order to practice as a licensed medical professional in Dubai. (i) ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use are as required by the marketing authorization or product specification; and Records of readings taken to check weight variation in case of capsules, (d) the approved therapeutic uses; The Tableting Section shall be free from dust and floating particles. Market your pharmacy (b) PH wherever applicable, 3.6.6 Follow-up action 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. [See rule 16 (6) (b)] Requirement for Assistant Pharmacy License Holder of a recognized assistant pharmacist certificate (viii) Light 3.2 Services 3.6 Complaints The text shall be fully legible. 9. 20A. 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. 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. 6.3.4 Obsolete materials 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. Records of tests employed :-- (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 (d) any directions for. 6.2.9 Correct dispensing Provided further that, if in the opinion of the Registration Board it is necessary so to do in the Public interest, it may provisionally register a [.] drug for period of two years. 14. (c) adequate arrangements shall be provided for carrying out the tests for strength potency, quality and purity of the drugs to be repacked. 6.9.4 Storage (8) Autoclave. 14. Checking integrity of filters (i) (1) Mixing equipment. (s) "formulation" means all operations involved in converting a drug into a final pharmaceutical dosage form ready for use as a finished drug including compounding, processing, formulating, filling, packing, finishing, labelling and other like processes; 52. Stability Summary : 7.1.4 Yield checks 113-54 (Drug Supply Chain Security Act). (b) "airlock" means an enclosed space with two or more doors, which is interposed between two or more rooms of differing classes of cleanliness for the purpose of controlling the airflow between those rooms when they need to be entered and an airlock is designed for and used by either people or goods; 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. 24. 17. (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; (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. 8. 3.1 General (c) toxicity or the side-effects. (3) Weighing and measuring equipment. SECTION--2 SECTION--5 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 . 4.6 Packaging Instructions Issuance of a drug-sales license or pharmacy license is a procedure given by the Pharmacy council of Pakistan (PCP). Liquid Paraffin Heavy. Quantity received. Develop a plan 4. 3.5.2 Suppliers audits 2. (A) The following equipment is required for the manufacture of drugs for external appliances or suspense: Requirement for Pharmacist License Must hold a pharmacy certificate from a recognized high institute, college or university. 3. Name of the sample. Serial number. (1) Strict sanitation shall be maintained throughout the entire plant in order to prevent contamination and to keep out pyrogens, Masks end overalls shall be worn wherever necessary. 22. (3) Polishing pan, where applicable, How to get Category A pharmacy license in Pakistan? Opinion and signature of the approved Analyst. SCHEDULE D-I how to apply dha exam for pharmacist. (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; 12. (af) "packaging" means all operations, including filling and labelling which a bulk drug has to undergo in order to become a finished product; 7.1.2 Material handling 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. Graduates Pharmacist Licensure by Examination for Non-U.S. Pharmacy Services Health Department KP. Practiced pharmaceutical profession for a period not less than two years (for foreigners) Fluent Arabic and foreign language. GENERAL CONDITIONS 4.9.1 Health examination 3.3.7 Stability studies If you want to do your own job as a pharmacist in the state of Maharashtra, then you . 10. 4.10 S.O.Ps Miscellaneous (2) An application under sub-rule (1) shall be countersigned by the head of the institution in which,. Male Female . (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. Suitability of process 10,000 prevent, the entry of air from outside. GOOD PRACTICES IN MANUFACTURING PROCESSING (3) Antiseptics and disinfectants for household use, excluding those containing hormone and antiniotics. Monitoring each cycle Changes, if any, in information furnished at the time of initial registration or last renewal 3. 15 Type of container : 4. Pharmacists who have completed all of the elements listed above can then apply for a license for the 1,000 hour clinical training programme. 6.2.1 Purchase 5.2 Dedicated Facilities for Production 4. (7) A new drug, where new method of manufacture is contemplated or a change is proposed in source, standard or specification of the active ingredient or the finished product, may not require full investigations and clinical trials except in so far as they are necessary for the purpose of establishing bio-equivalence, absorption, acceptability or other such features. (a) That licensee shall use the drugs manufactured under the licence exclusively for experimental purposes and shall carry on the manufacture and experimental work at the place specified in the licence. Filling and Sealing Room: Calamine. By way of basic Rs. (c) the statement of all the representations to be made for the promotion of the drug in respect of-- Disciplinary and criminal history for owners and officers of the pharmacy. [See rule 26(3A)] Both are non-refundable. 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