(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; (b) For the renewal of licence [See rule (31)1] APPLICATION FORM FOR REGISTRATION OF A DRUG FOR LOCAL MANUFACTURE SECTION-1 [See rule 20 (b)] Sterilized surgical lignature and sterilized surgical suture. A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. (ii) Dossage form(s) of drugs. 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 . 10.1.1 Maintenance of documents HTML PDF: 246-945-246: Wholesaler. 66. (g) Toxicity test, wherever applicable. (C) Equipment for the manufacture of Pills and Compressed Tablets including Hypodermic Tablets. 4.4 Prohibition of unauthorized person 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. _________________________ (c) Any other tests 6.10.1 Storage 10.4.5 Analytical records 20. 3.2 Basic requirements (c) infants. (2) In the exercise of their powers the members of the Central Licensing Board shall follow the procedure prescribed for the Federal Inspector - 5. 3. Whether the drug is registered for local manufacture or import 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. Click GO on the Apply/Manage a License and Service Requests tile. Note:-Strike off which is not applicable (b) The licensee shall allow a member of the Central Licensing Board or of a Provincial Quality Control Board or an Inspector to enter, with or without notice, the premises where the drugs are manufactured and to satisfy himself that the manufacture is being conducted for experimental purposes. Date of release of finished packings for distribution or sale, STEP 4: Apply for PSV. (3-B) Any application under sub-rule (1) or sub-rule (3) shall be accompanied by the proper fee specified in Schedule F. 4.9.7 Foods and drinks prohibited (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 Pharmacy Internship Report - Updated 2/11/20 (178.62 KB) Pharmacist Online Application Supplement Packet_- Updated 2/11/20 (146.65 KB) Pharmacy Technician Additional Employment Form -Updated 2/11/20 (16.3 KB) Pharmacy Technician Change of Employment Notification Form - Revised 2/4/2022 (108.64 KB) Pic Change Request Form - Updated 2/20/20 (75. . (ii) medical inspection of workers at the time of employment and periodical check up thereafter at least once a year; (j) reference to appropriate scientific literature ; and Licensing requirements for Michigan healthcare and pharmaceutical companies and individuals. Filter safety (i) the claims to be made for the drug; 14. Procedure 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. Alniminium Hydroxide Gel Dried. 2. (8) Autoclave. (7) Advertisement material shall be presented with courtesy and good taste and words and phrases implying urgency, uniqueness or such expressions which are absolute in character, such as "the most potent", "the most rapid", "the most efficacious", or which make exaggerated claims or to general claims, such as "effective in all cases" or "effective against all complaints" or superlatives shall be avoided. The training shall include instructions regarding appropriate ethical conduct taking into consideration the W.H.O. Duration of the exam is 2 hours 3. 39. (l-B) An application under sub-rule (l-A) shall be accompanied by the proper fee specified in Schedule F : and 5.3 General Requirements for Production Areas (4) The licensee shall maintain in the inspection book provided by the Central Licensing Board at the time of the issuance of the licence on which a member of the said Board or of a Provincial Quality Control Board or an Inspector shall record proceedings of each of his visits, his impressions and the defect or irregularities noticed, if any, by him and such inspection book shall be signed by him as well as the licensee or his authorised agent. Proviso: Added vide S.R.O. 7.3 Processing operations intermediate and bulk products SECTION-2 Year (i) 5. (iv) licence to manufacture by way of repacking; and (a) The generic name(s) of the active ingredient(s); Sterility test as the last measures No. MANUFACTURE BY WAY OF FORMULATION (i)All claims shall be made in accordance with these approved for registration of that drug. (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. Select correct technology 9. Phenothlazine (B. VET. 54. SCHEDULE D (14) The Licensee shall , by the 30th June and the 31st December each year, Whichever is immediately after the annual financial closing of the company. Date of filling. (i) if the application for renewal is made before the expiry of the validity of a certificate Rs. (c) "authorized person" means a person responsible for the release of batches of product for sale; 1. 6.8 Reagents and culture media DOCUMENTATION (al) "quality assurance" means the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use and so incorporates good manufacturing practices, Quality Control and other factors including product design and development and good laboratory practices; (a) Generic international non-proprietory name: Use of disinfectants and detergents 10. (i) Layout (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; 10,000 Specifications, with details of analytical procedure for each ingredient and the finished drugs (not required in case of a drug for which pharmacopocial standards recognised under the Drugs Act, 1976, are claimed). 2. (iii) Name of the approved expert staff. Methylene Blue. (iv) Validation 10.3 Batch processing records (j) One Surgeon, to be nominated by the Federal Government. 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. [See rule 16 (bb)-7] (3) Drier. (d) the approved therapeutic uses; HTML PDF: 246-945-245: Health care entity license. Sexual importance. (3) Name of the drug(s). 8. (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. ETHICAL CRITERIA FOR MEDICINAL DRUG PROMOTION You will need to pay a fee of 687, which covers the cost of processing your application. Cetrimide Powder. Powers of the Central Licensing Board: (1) The members of the Central Licensing Board shall exercise all the powers of an Inspector without restriction as to area, and shall have the powers of a Provincial Inspector in relation to Section 30. 4. 48. There are, in addition, other categories such as drugs miscellaneous pharmaceuticals such as Ferries Ammonii Citras. (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product; Production Department (ac) "master record" means a document or set of documents that serve as a basis for the batch documentation (blank batch record); (10) Rejection of an application for the registration of a drug shall not debar an applicant from submitting a fresh application under rule 26. 1993. (2) Kettle, gas or electrically heated with suitable mixing arrangement. A. Control reference numbers in respect of raw materials used. Safety instructions should be strategically displayed in local language. (3) Weighing and measuring equipment. Collaborate with a contractor 6. (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; 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. 31. open lesions or skin infection shall be engaged in production areas. Name of the Company .Type of ownership (Partnership, Proprietorship, Public limited, Private limited, etc.) (See rules 19 and 30) (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. 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. In order to avoid over-promotion, the main part of the volume of sales they generate. (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. . 11. Registration Board 3, Batch number (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. 37. 45.00 Initial Fee. (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. Records of test to be carried out in case of tablets as under 20A. (4) Antidandruff preparations. Ammonium Chloride. (e) any error in the labelling of that drug; 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. (c) toxicity or the side-effects. _________________________ (ii) Tableting Section; 15. (3) A suitable power driven mixer. Maintenance of equipment (1) Mixing and blending equipment. 10.3.1 General Name(s) of Proprietor(s)/Director(s)/Partner(s). Location and Surroundings . 5. 7.1.1 General DRUG MANUFACTURING LICENCE FEE Sodium Potassium Tartrate. The following equipment is required in each of the three sections :- Pharmacists measure and sell prescription drugs. FORM 6 (a) Description. (t) "good manufacturing practices for pharmaceutical products" means part of quality assurance which:-- 6.3 Workshops Pharmacist by Exam (Form LA-01E) Order a Fingerprint Card. (b) the labelling; 3.7.1 System 3.6 Complaints Note: Copies of balance sheets to be enclosed with the application for renewal only"; and 3.1 General (iii) Details of the section-wise equipment and machinery for manufacture and quality control. Sign in to start your session. SECTION--6 5.1 General responsibility of licensee HTML PDF: 246-945-235: Nonresident pharmacy license. Countersigned by .. 41. 3.4.6 Follow-up Action 45. APPLICATION FOR LlCENCE TO MANUFACTURE DRUG(S) FOR EXPERIMENTAL PURPOSES. Pack size (s) and proposed maximum retail price with the following details:- Ferrous Sulphate. license by examination or by license transfer the applicants who are qualified to engage in the practice of . Name of the sample. (2) Where a person possesses or applies for a licence to manufacture by way of formulation and he also intends to conduct repacking of drugs, he may conduct such repacking under the same licence subject to the approval of, and under such conditions as, the Central Licensing Board may specify. Once approved, the agency will schedule a site inspection. (9) No drug or any other substance shall be advertised in a manner which encourages self-medication or use to the extent that it endangers health. 8. 4.6 Rejected Materials 5. The Doctor of Pharmacy (Pharm.D.) FORM 5 Date of mixing in case of dry products, e.g., powder, powder mixture for capsule products, etc. Licensing Authority. 3.7.8 Storage of recalled drugs Date of granulation wherever applicable. 1. 10.1.8 Revision of specification 10.4.7 Recording batch distribution of the products for the manufacture of which the quantities have been issued and the particulars relating to the proper disposal of the stocks. By way of basic Rs. Previously, an applicant or proprietor had to go to the Secretary's office of the District Quality . 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; 47. (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. Potassium Iodine. First submit an application Central Licensing Board for establishment of a pharmaceutical unit. 7,500 Name and address of the agent or indentor in case of imported drug - 9.1 General In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meters is required. 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. Biological indicators Records of tests employed :-- Sterilization by moist heat HAAD License Requirements for nurses, HAAD License Requirements for pharmacist Classes are offered regular full-time base or part-time base. 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. Conditions or registration of drug: (1) The relevant provisions of the Ordinance and the rules in respect of the registered drug, shall be complied with. For Foreign-trained Pharmacy Graduates / Pharmacists. 5.1 General Facilities Sulphur Precipitated. (c) adequate arrangements shall be provided for carrying out the tests for strength potency, quality and purity of the drugs to be repacked. 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. wherever necessary (9) Miscellaneous. (b) if a clinical information for a drug is approved by the Drug Regulatory Authority in any of the said countries, the same clinical information shall be considered as approved for drug registration in Pakistan unless modified by the Registration Board on the basis of scientific data available to it, and such clinical information may include indication, contra-indications, side effects, precautions, dosage, etc; Central Licensing Board may from time to time permit. (b) the content of active ingredient(s) per dosage form or regimen; Note: Particulars regarding various tests applied (including reading and calculations) shall be maintained and necessary reference to these records shall be entered in serial No. 4. 4.8.2 Training appropriate to duties Form-7 License: This type of Drug sales license should be used for the sales of Medicines for Importers, Exporters, Indentors and Manufacturers. Register Lost your Password? 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: 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. (4) If the Registration Board, after such further enquiry, if any, as it may consider necessary, is satisfied of its safety, efficacy, quality and economical value or where the public interest so requires, it may register the drug and issue a certificate of registration in Form 6, subject to such specific conditions as it may specify.' Control reference numbers in respect of the lot of glass containers used for filling. The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. 7. Class A Class B Class C Class D Class E Business Apply Online Apply manually or In-person 2.1 General Medical Representatives.- (1) Medical representatives shall have an appropriate educational background. (c) Doors; Doors must be fire resistant preferably with self-closing system, Proposed dosage: (i)one copy of each issue of such journal or publication is sent to the Drug Administration of the Health Division; and (f) one pharmaceutical chemist or expert in quality control, to be nominated by the Federal Government; Find funding 5. CRF due C R F paid as per Col. 41 2 3 4 5 (3) Employers shall be responsible for the statements and activities of their medical, representatives. Potassium Permanganate. (b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that drug; PharmD Program Accreditation This professional degree program leading to the Doctor of Pharmacy degree is judged to meet established qualifications and education standards through initial and subsequent periodic evaluations. 58. 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