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Services Services Overview Product Registration Licensing Product Advertisement Clinical Trials Authorisation Imports and Exports Control Laboratory Services Market Control Capacity Strengthening Client Service Charter Inspections, Compliance, Enforcement, and Criminal Investigations Our everyday efforts to keep you safe Inspectorate ActivitiesThe FDA is committed to safeguarding the safety of our food and the efficacy of medical products we depend on. Inspections play a vital role in this oversight, involving meticulous on-site evaluations to ensure compliance with federal regulations. However, inspections are one part of our multifaceted approach to ensuring the ongoing safety and quality of FDA-regulated items.The FDA inspects the manufacturing and storage facilities of the below listed regulated products to ensure that manufacturing activities comply with the requirements of the current codes of Good Manufacturing Practices (cGMP) and storage and distribution conform to the requirements of Good Storage and Distribution Practices (GSDP).FoodAllopathic medicinesVeterinary medicinesVaccines and biological productsHerbal medicinesHomoeopathic medicinesFood supplementsMedical devicesCosmeticsHousehold chemical substances Enforcement ActivitiesAnother aspect of the FDA’s multifaceted approach to ensuring the ongoing safety and quality of FDA-regulated items is Enforcement.The Enforcement Directorate is a multi-disciplinary arm of the Technical Operations Division mandated to ensure compliance with the laws governing the regulation of FDA regulated products through investigation into malpractices and crimes, market surveillance and education. The Directorate relies on undercover personnel, confidential informants and sources as well as cooperating individuals to execute its mandate.The Directorate ensures that FDA regulated products imported into the country or manufactured locally and distributed for sale and consumption by the public conform to applicable standards and are safe, efficacious, and of the right quality for use.Activities include:1. Initiation and monitoring of the recall of products which are found not to have met regulatory requirements or are non-compliant with set standards 2. Sampling and testing, market surveillance, product quality monitoring and product verification done to ensure that counterfeit, falsified and unwholesome regulated products are prevented from entering the market or removed from the market to protect public health and safety 3. Investigations into and prosecutions of all issues of non-compliance of regulated products 4. Monitoring of advertisements of FDA regulated products to ensure compliance 5. Raids and swoops in markets for non-compliant products Forms and Guidelines Application form for Safe Disposal Inspection checklist, technical report Guideline on Safe Disposal of Unwholesome Products Guideline on Product Recall — Official PDF notice (extracted text) — No. 17 Indian Ocean Street, Nelson Mandela Avenue, Shiashie ● Greater Accra ● Ghana P. O. Box CT 2783, Accra ● GPS: GA-237-7316 ● (+233) 302 233200 / 235100 ● fda@fda.gov.gh © FDA-GHANA, 2024. Reproduction is authorized provided the source is acknowledged. FOOD AND DRUGS AUTHORITY 7 th August 2023 FDA/OPS/GDL - 02/02 Guideline on Product Recall Draft written by Enforcement Directorate N/A Draft reviewed by QMS N/A Start of public consultation N/A Adopted by FDA Governing Board 15 th March 2019 Final Quality Assurance Review 24 th July 2023 Approved by CEO 28 th July 2023 Date of coming into effect 7 th August 2023 This guideline replaces ‘Guideline for Product Recall' (FDA/DRI/DMS/GL-PRL/2019/05). Guideline for Product Recall FDA/OPS/GDL - 02/02 Page 2 of 12 Document Revision History Date of Revision Version Number Changes made and/or reasons for revision 20/03/2019 01 Initial issue of Guideline 07/08/2023 02 To cover all FDA- regulated products. Inclusion of definition for substandard and falsified products. Guideline for Product Recall FDA/OPS/GDL - 02/02 Page 3 of 12 Guideline for Product Recall Table of Contents Document Revision History .......................................................................................... 2 1.0 Introduction (background) .................................................................................... 4 1.1. Legal Basis................................................................................................................ 4 1.2. Scope ........................................................................................................................ 4 2.0 Definitions and Abbreviations .............................................................................. 4 2.1 Definitions .................................................................................................................. 4 2.2 Abbreviations in this guideline: ................................................................................... 5 3.0 Requirements ......................................................................................................... 5 3.1 Requirements for Recall Initiation .............................................................................. 5 3.2 Product Recall Trigger ............................................................................................... 6 3.3 Recall Classification ................................................................................................... 7 3.4 Levels of Recall .......................................................................................................... 7 3.5 Timelines for Effective Recall System and Rapid Alert .............................................. 8 3.6 Procedure for Rapid Alert and Recall System: ........................................................... 8 3.7 Recall Communication ............................................................................................... 9 3.8 Effectiveness Checks ............................................................................................... 10 3.9 Post Recall Notification to FDA ................................................................................ 10 3.10 Disposition of Recalled Products ............................................................................ 10 3.11 Termination of Product Recall ................................................................................ 11 4.0 PENALTIES ............................................................................................................. 11 Annex ............................................................................................................................ 12 A1. OVERVIEW OF PROCESS FLOW FOR RAPID ALERT AND RECALL SYSTEM 12 Guideline for Product Recall FDA/OPS/GDL - 02/02 Page 4 of 12 1.0 Introduction (background) The Food and Drugs Authority (FDA) is established under the Public Health Act, 2012, Act 851 to ensure public health and safety by regulating the manufacture, importation, exportation, storage, distribution, use and advertisement of food, drugs, herbal medicinal products, cosmetics, medical devices and household chemical substances. Recalls are an effective method for removing or correcting marketed products, their labelling, and/or promotional literature that violate the laws administered by FDA. Recalls afford equal consumer protection but generally are more efficient and timelier than formal administrative or judicial actions, especially when the product has been widely distributed. FDA regulated firms may initiate a recall at any time to fulfil their responsibility to protect the public health from products that present a risk of injury or gross deception or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA, in response to a formal request by FDA, as statutorily mandated or as ordered by FDA. These guidelines are hereby made for information, guidance and strict compliance by all concerned. 1.1. Legal Basis The Authority is responsible under section 123 of the Public Health Act, 2013 (Act 851) to initiate and supervise the product recall of non-compliant products including Substandard/Falsified products. 1.2. Scope To explain and standardize the procedure for product recall in order to ensure effective removal and disposition from the market products that violate requirements and that may present a health hazard to the consumer/user. 2.0 Definitions and Abbreviations 2.1 Definitions "Product" means any locally manufactured or imported food, drug (allopathic, herbal, food supplements, biological & vaccines, veterinary), medical devices, cosmetics, household chemicals, investigational products and any Advertisement thereof as defined under the Public Health Act, 2012 Act 851. “Substandard” these are authorized medical products that fail to meet either their quality standards or specifications, or both. “Falsified” medical products that deliberately/ fraudulently misrepresent their identity, composition, or source. Guideline for Product Recall FDA/OPS/GDL - 02/02 Page 5 of 12 “Recall" means a firm's removal from further sale, distribution or use, or correction, of a marketed product that does not meet regulatory requirements as specified in the Public Health Act and/or violates FDA guidelines. “Voluntary Recall” is when a firm requests a product recall after discovery of safety issues, product defects or non-compliance to regulatory requirements. Statutory (Non-Voluntary) Recall” is when FDA requests/orders a product recall due to non-compliance to regulatory requirements. "Correction" means repair, modification, adjustment, re-labelling, or inspection (including patient monitoring) of a product without its physical removal to some other location. "Recalling firm" means the firm that initiates a recall. It is usually the firm that has primary responsibility for the manufacture/import and marketing of the product to be recalled. "Product withdrawal" means a firm's removal from further sale or use, or correction of a marketed product that does not violate legislation administered by the FDA. It is not considered to be a recall. "Stock recovery" means a firm's removal or correction of a product that has not been marketed or that has not left the direct control of the firm. It is not considered to be a recall. "Recall strategy" means a planned specific course of action to be taken in conducting a specific recall, which addresses itself to matters such as the depth of recall, need for public warnings, and extent or effectiveness checks for the recall. The definition of "Recall" does not include a "product withdrawal" or a "stock recovery". 2.2 Abbreviations in this guideline: CAPA - Corrective and Preventive Action FDA - Food and Drugs Authority HCP - Healthcare Professional MAH - Market Authorization Holder QA - Quality Assurance SF- Substandard and Falsified Products 3.0 Requirements 3.1 Requirements for Recall Initiation 3.1.1 Initiation of Statutory (Non-Voluntary) Recall: The Authority shall be responsible for requesting/ordering a product recall when the registration of a product is cancelled for safety reasons, or when the product does not meet regulatory requirements. Guideline for Product Recall FDA/OPS/GDL - 02/02 Page 6 of 12 3.1.2 Initiation of Voluntary Recall - It is the recalling firm’s sole responsibility to request and implement the recall process by contacting all companies to whom the recall products have been distributed and ensuring the physical removal of the products from the market to the level required. 3.1.3 If the recalling firm’s actions are deemed inadequate the Authority will take appropriate actions to remove the product from sale or use. A firm's recall does not preclude enforcement actions being taken by the FDA, as deemed appropriate, either during or following the completion of a recall. 3.1.4 In such instances, the Authority shall monitor the effectiveness of the recalling firm’s actions and provide scientific, technical, and operational advice where necessary. In such cases prior notice should be given to the Authority. 3.2 Product Recall Trigger Any product / batch(es) not meeting the defined quality standards must be recalled from the market. Recall can be of two types: Voluntary Recall and Statutory Recall. 3.2.1 Voluntary Recall Voluntary recall can be triggered by any incident that affects the quality, safety, and efficacy of the batch/product in question such as Batch(es) not complying with regulatory specifications during the post marketing stability study. Batch(es) found to be defective during investigation of market complaint. During any failure investigation, if it is observed that the failure under investigation might have adverse quality impact on already released batch (e.g., possibility of contamination, mix-up, degradation etc.). If any unusual observation is noted during visual inspection of retention samples which indicate an impact on quality of the product after investigation. If the post marketing surveillance reports /pharmacovigilance reports indicates that there is serious safety risk associated with the product 3.2.2 Statutory Recall (Non-Voluntary) Statutory recall of products or batch(s) from the market by the Authority may be triggered by the: Product/batch identified to be in violation of requirements, such as substandard, falsification etc. Serious reports of adverse drug reactions not included in the package insert. Unexpected frequency of adverse reaction stated in the package insert. Products banned by the Authority. Products for which the market authorization have been withdrawn/cancelled. Labelling and / or Promotional materials that are in violation of regulations. Guideline for Product Recall FDA/OPS/GDL - 02/02 Page 7 of 12 3.3 Recall Classification The Authority shall assign numerical designation, i.e. I, II or III, to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled. The following classifications shall apply: Class I: A dangerous or defective product that could cause serious health problems or death. Class II: A product that might cause a temporary health problem or pose slight threat of a serious nature. Class III: A product that unlikely to cause any adverse health reaction, but that violates FDA labelling or manufacturing laws. 3.4 Levels of Recall The level (or depth) of recall of a product/batch shall be determined based on recall classification and level to which distribution has taken place. There are three levels of recall namely, consumer/user, retail, and wholesale. Table 1 – Recall Type, Depth and Action Recall Type Depth of Recall Action A Consumer or User Level Recall is designed to reach all suppliers of medicines (all distribution points) i.e. wholesalers, hospitals pharmacies (private / public hospitals), retail outlets, and individual customers or patients through media release (TV, radio, print media, social media etc.) Recall letter to manufacturer/impo rter to be initiated at all levels of distribution plus media release. Recall Type Depth of Recall Action B Retail Level / User facilities Recall is designed to reach wholesalers, hospital pharmacies (private / public hospitals), retail outlets Recall letter to manufacturers / importers and HCPs C Wholesale Level Recall is designed to reach wholesale level and other distribution points. This can be achieved by means of representatives calling on wholesalers and/or retail outlets. If it is known where the product in question had been distributed to, specific telephone calls or recalls letters to arrange for the return of the product could be made Recall letter to manufacturers, importers/wholesal ers Guideline for Product Recall FDA/OPS/GDL - 02/02 Page 8 of 12 All Class I recalls shall be executed to the levels of Wholesale/Distributors, retail, and consumer. In such cases, public announcements shall be made using print/electronic media aids viz. Newspapers, Television, Radio etc. All Class II recalls shall be executed up to the levels of wholesale and retail. All Class III recalls shall be executed up to the levels of wholesale. 3.5 Timelines for Effective Recall System and Rapid Alert The following timelines shall apply to product recalls. Table 2: The timeline for initiating and stopping sale/distribution of defective product Recall Class Initiation Timeline Physical Recall Timeline Class I 24 Hours 72 Hours Class II 48 Hours Up to 10 Days Class III 72 Hours Up to 30 Days 3.6 Procedure for Rapid Alert and Recall System: The following steps shall be taken when a recall is initiated: FDA/TOD/ENF/OPS/GL- PRL/2023/05 As soon as the product/batch(es) to be recalled is/are identified, Market Authorization Holder or local agent or QA in charge shall review the information related to the defective product/batch(es) and decide about recall as per the procedure established. The decision on recall of the defective product/batch shall be made within 24 Hours up to maximum of 72 Hours for Class I recall upon receipt of the recall information. Within 24 Hours of the decision taken for the recall of the product/batch(es), the communication shall be sent stating the severity of the defect, using the fastest mode of communication which may include email, telephone, social media, text (SMS) etc. to the entire supply chain. The MAH/Local Agent where the product is marketed shall inform the concerned regulatory authorities where the product batch(es) in question was distributed immediately after the decision of recall has been taken. Further actions on recall will be undertaken according to class of recall. It is the responsibility of the recalling firm (Marketing Authorisation Holder (MAH)/ Local agent) immediately after discovering the problem to officially notify distributors to suspend sale and/or further distribution of the product in question. Details of notification Guideline for Product Recall FDA/OPS/GDL - 02/02 Page 9 of 12 shall include but not limited to: Name, strength, batch and any other pertinent descriptive information of the product Reason for the recall Suggested action to be taken and its urgency Provide specific instructions on what should be done with the recalled product Follow-up communications should be sent to those who fail to respond to the initial recall communication Records of the recall notice, available stock and returned stock from various outlets shall be maintained by the recalling firm and shall be made available for verification by FDA regulatory officers. 3.7 Recall Communication 3.7.1 General A recalling firm is responsible for promptly notifying each of its affected distribution outlets about the recall. The format, content, and extent of a recall communication Page 6 of 10 FDA/TOD/ENF/OPS/GL-PRL/2023/05 That the product in question is subject to a recall; that further distribution or use of any remaining product