(3) Advertisements under sub-rule (2) shall be subjected to the following conditions, namely :-- 2.4 Products manufactured under aseptic conditions Date of compression in case of tablets/date of filling in case of capsules. PREMISES 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 12. Process to apply for a Drug sales License: 1) Fill a prescribed form-5 in Drug Rules. The system includes the following modules: Pharma Council Module: Designed for Pharma Council to verify qualified person/pharmacist (s) credentials. (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; 5. (12) The licensee shall on being informed by the Central Licensing Board or a Provincial Quality Control Board that any part of any batch of a drug has been found not to conform with the requirements of the Ordinance or the rules and on being directed so to do, withdraw the remainder of the batch of such drug from sale and, so far as may in the particular circumstances of the case be practicable, recall all issues already made from that batch and dispose it of in such manner as may be directed by the said Board. Analytical report number. 62. (iii) licence to manufacture by way of formulation; (h) any unexpected side effects, injury, toxicity or sensitivity reaction associated with the clinical uses, studies, investigations and tests respecting that drug; and 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. Protocols of tests applied. Patent number, if any, with date and its date of expiry : (c) The manufacture shall be conducted under the active directions and personal supervision of competent technical staff consisting of. (G) The following equipment is required for the manufacture under aseptic conditions of Eye-Ointments, Eye-Drops, Eye-Lotions and other use :- 7.2.2 Measures against contamination Using double filter layer (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; (6) In the absence of the Chairman, the Board may elect one of its members to preside over a meeting. 10. 9. 3.7.8 Storage of recalled drugs 15 Type of container : 3.7.3 Written procedures 4.1 General Protocols of tests applied The following equipment is required in each of the three sections :- 20. (i) Class(es) of drugs. (f) one pharmaceutical chemist or expert in quality control, to be nominated by the Federal Government; (2) Graduated delivery equipment for measurement of the medicament. 6.2.11 Labelling No. (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-- 2.2 Terminally sterilized products (2) No person who is a member of the Appellate Board shall be nominated to the Central Licensing Board. 3. Wrapping materials CERTIFICATE OF REGISTRATION FORM-5B 4.5 Sampling 6.9.1 Testing prepared reference standard (c) two pharmacologists, to be nominated by the Federal Government. 4.9 Weighing Area This licence permits the manufacture of Bio-availability studies: Washing of clothing (m) "compounding" means scientific combination of two or more ingredients with a view to make a finished drug; and detailed records must be kept. 4. 13. Retailer's discount: The retailers discount shall be 15% of the maximum retail price. Attested copies of the last two income tax assessment orders of the Income Tax Department attached. Borax. 6, Results of tests applied. Information for patients contained in package inserts, leaflets and booklets.- (1) Adequate information on the use of drugs shall be made available to the patients where it is necessary for rational use of a drug. Dose and volume of solution injected into each rabbit and time of injection. (i) if the application for renewal is made before the expiry of the validity of a certificate Rs. (iii) Coating Section. Magnesium Trisilicate. SECTION-3 Recording sterilization cycle prevent, the entry of air from outside. to be nominated by the Federal Government. 3.7.4 Recall with promptness 25,000 7.4.10 Discrepancies to be investigated 3. For any pharmacy technician applications submitted online from June 2, 2020 thru August 31, 2021, the registration fee is $70.00. 5 whenever necessary. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. Calcium Carbonate. 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. Provided that such variation shall be recorded in writing with reasons therefor and also communicated in writing to the manufacturer for his record, 24. (b) Identification. (3-A) Application for renewal of registration of a drug shall be made in Form 5-B. is/are hereby licensed to manufacture by way of Basic Manufacture/Semi Basic manufacture/Formulation/Repacking at the following premises:- (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. Class A Class B Class C Class D Class E Business Apply Online Apply manually or In-person Signature of the Analyst. Whether the drug is registered for local manufacture or import Fax - (717) 787-7769. Serial number. 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. 4.3 The contract shall be describe clearly who is responsible for purchasing, testing and releasing materials and for undertaking production and quality controls, including in-process controls, and who has responsibility for sampling and analysis, and in the case of contract analysis, the contract shall state whether or not the contract acceptor shall take samples at the premises of the manufacturer. Pharmacists will have to arrange their own internship in either a hospital or community pharmacy setting. In case medicated dressings are to be manufactured, room with an area of minimum of 300 square feet shall be provided. Signature of the expert staff responsible for the manufacture, STATEMENT SHOWING QUARTERLY PRODUCTION TO BE SUBMITTED IN DUPLICATE Date of mixing in case of dry products, e.g., powder, powder mixture for capsule products, etc. Pay your fees using internationally accredited credit cards e.g. Name of the Sample Invoice/Challan number and date. ------------------------ May include compounding Non-Resident Use of protective garments 6. Brights disease, cataract, glaucoma, epilepsy, [] lacomotive ataxia, multiple sclerosis, lupus, paralysis, blindness. 4.5 The contract shall describe the handling of starting materials, intermediate and bulk products and finished products if they are rejected and it shall also describe the processing of information if the contract analysis shows that the tested product must be rejected. Box 2649. (u) "half-finished product" means any material or mixture of materials that has to undergo further manufacture; (8) Jar or tube filling equipment, where applicable. 14. Sodium Bicarbonate. 6.10 Waste materials 2 Examinations. Pix Carb. 3.6.4 Recording defects and investigation (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; Pharmacological and clinical data : 1,000 per advertisement. (a) recommended clinical use and the claim to be made for the drug. VALUE (in Rs.) DOCUMENTATION 4.8.5 Visitor and untrained personnel discouraged 33. 3.7.9 All concerned to be informed [See rule 16 (bb)-7] III. (c) the generic name(s) of other ingredient(s) known to cause problem(s) 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. Medical Representatives.- (1) Medical representatives shall have an appropriate educational background. 10.1.6 Reference standards identification 10,000By way of semi-basic Rs. (a) animal or clinical investigations and tests conducted by the manufacturer or reported to him by any person concerning Sterilization by heat Statement of the Central Research Fund. 20. 14. Pack size. 22-04 to avoid a healthcare workforce shortage emergency. 9. Advertisements shall also indicate, where applicable, appropriate limitations to the use of the drug. Panamanian domestic regulations also require that the . CONDITIONS FOR GRANT OF A LICENSE TO MANUFACTURE BY WAY OF FORMULATION 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. All emergency and safety equipment must be frequently and regularly checked and maintained to ensure its conditions satisfactory. 7.4.3 Labeling packaging line 4. 34. 6.3.4 Obsolete materials Records of the disposal of rejected batch and batches with-drawn from the market. open lesions or skin infection shall be engaged in production areas. Chairman and the Secretary, and its members-shall hold office for such term, as is prescribed for the Central Licensing Board set up under rule 8. 3.3.5 Test Requirement for Finished Products Sterility testing Name of Drug(s). 7.2.4 Microbiological monitory Tannic Acid. (i) Equipment (a) for adults. 58. 6.2.10 Checking SECTION--4 26. 3.7.5 Distribution records CONDITIONS OF FACTORY PREMISES Calcium Lactate. 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. Ferric Ammonium Citrate. (a) rupees one thousand for the registration of new drug; (iii) Name of the drug(s) registered/approved. 24. 2. (g) Toxicity test, wherever applicable. 2. 4.6 Packaging Instructions I.being a person resident in Pakistan, carrying on business at (full address) under the name of(and being an importer/indenter/authorised agent of ), do hereby give this warranty that the drugs here-under described as sold/indented by me/specified and contained in the bill of sale, invoice, bill of lading or other document describing the goods referred to herein do not contravene in any way the provisions of section 23 of the Drugs Act, 19.76. (D) The following equipment is required for the manufacture of Powders :-- (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging; DETAILS OF THE FIRM Pharmacist-in-charge information, including license number. 9.2.1 Validation of critical processes RESPONSIBLE PERSON REQUIREMENTS FOR LICENSURE Updated 12/5/2022 Pursuant to rules 4729:5-2-01 and 4729:6-2-01 of the Ohio Administrative Code, the Board . (2) In the exercise of their powers the members of the Central Licensing Board shall follow the procedure prescribed for the Federal Inspector - Precursor substance requirements for the sale of a restricted product. (3) A suitable power driven mixer. (a) for adults. Equipment maintenance Potassium Permanganate. PARTICULARS TO BE SHOWN IN MANUFACTURING RECORDS (a) A complete description of and date derived from studies on the stability of new drug, including information pertaining to the suitability of the analytical methods used To LOG IN or CREATE a DELPROS (Delaware Professional Regulation Online Services) user account: Go to: https://delpros.delaware.gov/OH_HomePage. Following statement, as per audited accounts/based on Income Tax Return for the last five years:- 10.4.4 Recording batch numbers SECTION--3 1. For the quarter ending. (2) Analgesic Balms/Plasters. 16. Pack size (s) and proposed maximum retail price with the following details:- (6) Sintered glass funnel, seitz filter or filter candle. Although health education aimed at children is highly desirable, drug advertisements shall not be directed at children. Personnel 18. Calcium Gluconate. or at such other place(s) at the. Rs. 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. 7.4.7 Resistant printing on labels HTML PDF: 246-945-235: Nonresident pharmacy license. Number of containers filled. 13. All arrangements for production and analysis must be in accordance with the registration and agreed by both parties. 6.7.1 Recalled products Processing 35. Date of release of finished packings for distribution or sale, 6.3 Packaging materials Perform location analysis 3. 5. Manufacture on more than one set of premises: If drugs are manufactured on more than one set of premises, a separate application shall be made and a separate licence shall be issued in respect of each such set of premises. Note /: The above requirements of this schedule are subject to modifications, at the discretion of the Central Licensing Board if it is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter in the circumstances of a particular case: A total area of not less than 900 square feet for the three Sections is required for basic installations. (az) "system" means a regulated pattern of interacting activities and techniques which are united to form an organized whole; Patent number, if any, with date and its date of expiry. 21. (iv) Validation 4.3 GMP awareness 2. 10.2 Specification for intermediate and bulk products 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. 8. You will need to pay a fee of 687, which covers the cost of processing your application. Alniminium Hydroxide Gel Dried. 7. The licence is subject to the conditions prescribed in rule 22 of the Drugs (Licensing, Registering and Advertising) Rules, 1976, and such other conditions as n3ay be subsequently prescribed or Specified by the Central Licensing Board in this behalf. Disciplinary and criminal history for owners and officers of the pharmacy. SECTION -- 5 3. (2) Moulding equipment. 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:- Licensing Requirements. 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:- Date of issue .. 7.1.6 Labelling Find funding 5. 3.3.6 Production record/batch review 5.1 General responsibility of licensee 29. Chloral Hydrate. Results of assay. (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. 10.1.1 Maintenance of documents (e) Testing, 1. 10.4 Batch packaging records Duration of the exam is 2 hours 3. Pharmacy (In-State Only) License. (5-A) Where the Registration Board registers a new drug, it may recommend to the Federal Government for fixation of maximum price of such drug. 53. . MANUFACTURE BY WAY OF FORMULATION Captcha: 9 + 4 = Sign In. (ii) Tableting Section; 44. 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