3. 4.8.5 Visitor and untrained personnel discouraged (p) "cross-contamination" means contamination of a staring material intermediate product, or finished product with another starting material or drug during production; 7. PRACTICE OF PHARMACY AS A PROFESSION. There have been/have not been any change in respect of 24 may be advertised to the medical, pharmaceutical and allied professions, without referring to the Federal Government, through medical representatives or through professional journals and publication which are meant for circulation exclusively amongst the members of the medical, pharmaceutical and allied professions (f) Pyrogen test, wherever applicable. 4. 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. Use of protective garments 3. 7.3 Processing operations intermediate and bulk products (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. (bb) "wholesale" means sale to a person who purchases for the purpose of selling again and includes sale to a hospital or dispensary, or to medical, educational or research institute. SCHEDULE B-II (a) rupees one thousand for the registration of new drug; (a) recommended clinical use and the claims to be made for the drug. HTML PDF: 246-945-246: Wholesaler. Provided further that duration of a licence issued under rule 21 shall be two years unless earlier suspended or cancelled. (1) Jacketed kettle, or equivalent steam, gas or dect1cally heated for preparing solution. (i) the claims to be made for the drug; 2. Find funding 5. 4.9.4 Reporting health problems Bio-availability studies: Precursor substance requirements for the sale of a restricted product. 3. 3. 6.6.3 Batch recovers (j) Cost Accountant of the Ministry of Health; (i) Name of the proprietor/directors/partner(s) 1.Analytical report number (b) Identification. 30. MATERIALS 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. Pharmacy Technician (Category-B) diploma holder is eligible to apply for license to open own medical store. Precautions during cooling In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meters is required. 3.6.7 Recording measures Investment Turnover Profit before tax Percentage 1% before tax for Central Research Fund percentage of Profit The following are minimum requirements for obtaining drug license or starting a pharmacy in India: Area: The minimum area of 10 square meters is required to start a medical shop or pharmacy or wholesale outlet. (3) When a licence is cancelled or suspended, an entry to that effect shall be recorded on the licence. The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. 6.10 Waste materials Licensing Requirements. Tableting Section: The training shall include instructions regarding appropriate ethical conduct taking into consideration the W.H.O. (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; Pharmacies must also be registered with the GPhC (or be a pharmacy department based in a hospital or health centre) to operate in Great Britain and to use the title 'pharmacy'. Any wording and illustration on the package and label shall conform to the principles of ethical criteria enunciated in this Schedule. Name of the drug. 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. (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-- 3. 7,500 (13) Inspection table with draft and light background 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. 14. Cetrimide Powder. 3.7.8 Storage of recalled drugs Details of Disposal 5. 113-54 (Drug Supply Chain Security Act). Japan, USA and European Company Member countries. Comparison of products shall be factual, fair and capable of substantiation. Advertisements in any form to the general public.- (1) Advertisements to the general public, where permissible, shall help people to make rational decisions on the use of drugs determined to be legally available without a prescription. Name and address of the manufacturer (3) Punch and dyes storages cabinet. Signature of the Analyst. (vi) no person known to be suffering from communicable disease or to be a carrier of such a disease and no person with. [See rule 7] GOVERNMENT OF PAKISTAN Entry restricted SCHEDULE B-III 2. 18. (g) the Drugs Controller, Ministry of Health, Government of Pakistan who shall be its ex-officio Secretary; (ag) "packaging material" means any material, including printed material, employed in the packaging of a pharmaceutical product, excluding any outer packaging used for transportation or shipment and packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product; SECTION -- 7 Amenorrhoea metrorrhagia, memorthagia, metrosalpingitis, ovaritis, fibromas, cysts. 1. 6.2.9 Correct dispensing ENCLOSURE OF THE APPLICATION FOR REGISTRATION OF A DRUG (a) Clarity, Name and address of the manufacturer: Proposed shelf life with storage conditions, if any : Sodium Salicylate. 9.2.1 Validation of critical processes (c) Uniformity of weight. 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. (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. 48. Summed response, Types of licences to manufacture drugs: Licences to manufacture drugs shall be of the following types, namely :-- The system includes the following modules: Pharma Council Module: Designed for Pharma Council to verify qualified person/pharmacist (s) credentials. (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. 8. [See rule 21(I)] SECTION -- 10 To verify a wholesale drug distributor is licensed in the state (s) where it is. 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. Sterilization PART-II 6.3 Workshops 4.7 Duties of Quality Control Incharges SECTION -- 7 SECTION--5 1. (4) In the room provided for aseptic filling and sealing, necessary measures for maintaining sterility and to preventing contamination shall be adopted. of tablets, injections tubes litres etc. Dosage from of the drug: APPLICATION FORM FOR RENEWAL OF A LICENCE TO MANUFACTURE DURGS BY WAY OF FORMULATION/BASIC MANUFACTURE/SEMI-BA SIC MANUFACTURE/REPACKING 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. Name of the manufacturer/supplier. 9.1 General SCHEDULE F Rs. Sterilized non-sterilizer products differentiation Islamabad | Karachi | Lahore | Peshawar | Quetta; Phone: 0800-03727 (Mon to Fri 08:00AM to 04:00PM) Website: www.dra.gov.pk; Information on price to the consumer shall be accurately and honestly portrayed. 10. QUALITY CONTROL DEPARTMENT 3.3.2 Sampling Dated Signed It is certified : 7.1.2 Material handling 2. 2.4 Products manufactured under aseptic conditions (7) Liquid filling equipment. (11) Bacteriological filters such as Seitz filter, candles or sintered glass filters, 9. Provided that an application for renewal shall not be entertained unless it has been made within sixty days after the expiry of the licence and when an application has been made as aforesaid the licence shall subject to the orders passed on the application for renewal continue in force for the next period of two years. 8. P.O. (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. 3.4.2 Items for self inspection FORM 3 Date of granulation wherever applicable. SECTION -- 4 Name of Manufacturer. 29. Introduction . FORM 7 3. 5. The application fee is $147. (ii) licence to manufacture by way of semi-basic manufacture; In order to become a licensed pharmacist, you must hold a Doctor of Pharmacy (Pharm.D.) Name of the material Sterility testing 11. in Pharmacy. Glycerin. (d) Volume in container, (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. 12. 2. 4. (c) rupees two hundred and fifty for the renewal of the registration of a new or any other drug: (i) Equipment (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. 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.. Date of mixing in case of dry products, e.g., powder, powder mixture for capsule products, etc. (iv) Services 3.3.4 Test requirement for in-process controls 10.1.5 Product labelling 10.4.5 Analytical records (2) Capsule filling units. 6.4 Animal House Potassium Iodine. (3) A suitable power driven mixer. 23. 10.4.9 Equipment logbooks 8. Provided that the Central Licensing Board may allow a portion of such contribution to be spent by the firm itself for research and development of new drugs or for establishing research laboratories when it is fully satisfied that such expenditure will be utilised for the said purpose effectively and properly. 3. 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. 4.3 Specifications for Starting and Packaging Materials 4.5 Duties of Heads of Departments 4.9 Personal hygiene 15,000 (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". Personnel Proviso: Added vide S.R.O. that drug; Though licensing applications and processes differ from state to state, everyone will need the following: Proof of graduation from an accredited institution;

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