with stronger international presence - LABIALFARMA · LABIALFARMA GROUP. with stronger international presence. More information on . page 6 NEWS. 10. QUARTERLY 2013. The end of the

LABIALFARMA GROUPwith stronger international presence

More information on page 6 �

NEWSQUARTERLY 2013

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The end of the PortugueseNotified Body (INFARMED – NB) THE VIGIA SYSTEM Food Supplements

Certified medical devices: what happens now?Meet the current scenario and learn how you can market this kind of product with medical purposes.


Support service for consumers and healthcare professionals to clarify doubts regarding the use of dietary supplements, teas and concomitant products.


Quality control of these products is essential and integral part of the Good Manufacturing Practices implemented in LABIALFARMA.


NEWSQUARTERLY | JULY | 201310

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EDITORIAL

ETHICS AND SOCIAL RESPONSIBILITY

In the contemporary business corporation it has become common practice to adopt a set of measures that go beyond the borders of its exclusively economic interests and that results into a serious and permanent commitment of the company to improve the quality of life and physical, mental and social well-being of the society in general and of the local community in particular.

In the case of LABIALFARMA, social responsibility plays a strategic role in its concerns, embodying the assumption of a perfectly voluntary set of measures of economic, social and environmental natures, which is quite well visible through the several projects supported by the Company that contribute ineluctably to its sustainable development.

In a globalizing era as we live in, the old idea that investing in ethical and social values causes the reduction of profits is put aside. On the contrary, it may, if combined with a well prepared policy of social marketing, add value and benefits to the brand image.

In times where organizations live a credibility crisis, socially responsible companies must show both the transparency of their actions as the defense of ethical principles of relationship and behavior in daily practice of their activity. This is indeed the case of LABIALFARMA.

Lauric Acid:a pleasant surprise among saturated fats!

Lauric acid, also properly known as dodecanoic acid, is a unique medium-chain fatty acid commonly found in plant oils, as well as in milk. Research suggests it can have multiple health benefits far beyond the basic nutritional value.

The pure coconut oil is the most abundant natural source available in lauric acid (containing about 50%). Lauric acid was first discovered when microbiologist Jon Kabara studied the human breast milk, to determine antiviral substances responsible for the protection of infants against infections. In our body, lauric acid is converted to monolaurin (derived monoglyceride). This molecule has anti-infective properties against various microorganisms such as bacteria, fungi, protozoa or viruses. This effect occurs through three possible mechanisms:

• Fluidizeslipidsandphospolipidsofbacteria’scellularmembraneandvirus envelope;

• Interfereswithsignaltransductionandtoxinformation;

• Stimulates the immune system, by increasing the proliferation ofTlymphocytes.

DID YOU KNOW…

Lauric acid is an excellent option to reinforce the natural body defenses and to fight a whole range of pathogens. Its supplementation is very interesting for all consumers, especially in this unsettled summer and preparing the colder seasons.

Ricardo DeusProject Manager / Regulatory Affairs, NUTRI.ADD, S.A.

JorgeSerraDeputy to the BoardLABIALFARMA Group


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The greatest advantages are that neither it induce any resistance, nor unfavorably affects any symbiotic bacteria of our body.

Even with all these benefits, it should be noted that the lauric acid content in the European diet is minimal and the healthy coconut oil is unusual in our cuisine, instead of highly refined industrialoils.Therefore,lauricacidhasbeenexploitedasafoodsupplement, being particularly employed as a complement of antibiotics (enhances their activity), immunostimulant (in flu, cold, onychomycosis, recurrence of herpes, etc.) and energy source(forathletesandChronicFatigueSyndrome).

References:

• Natural Medicines Comprehensive Database Web site: http://naturaldatabase.therapeuticresearch.com/home.aspx?cs

• FIFE,Bruce–TheCoconutOilMiracle.PenguinGroupUS,4thEdition,September9,2004.

• KABARA,Jon–LipidsasAntimicrobialAgentsagainstResistantOrganisms.The Original Internist, Dec 2008, Vol. 15(4), p.181(8)

- Cytomegalovirus

- Herpessimplexvirus

- syncytial virus

- influenza virus

- Rubella Virus

- pneumovirus

- Staphylococcus aureus

- Neisseria gonorrhea

- Listeria monocytogene

- Helicobacter pylori

- Chlamydia trachomatis

- Streptococcus A,B, F & G

- Aspergillus niger

- Candida albicans

- Severalringwormspecies

The various pathogens sensitive to monolaurin include:

CURIOSITIES

The first clinical investigation was recorded 266 years ago and involved dietary supplementation. We refer to the famous trials of James Lind using oranges, lemons and cider as a treatment for scurvy.

The inhabitants of Ikaria Island (Greece) have the highest life expectancy in the world, with 10 times more nonagenarians than in the rest of Europe. This phenomenon has long intrigued scholars and seems to be closely related to its diet. Recent studies point the polyphenols and antioxidants of Greek coffee as the secret to this healthy and long life!

LABIALFARMA helps you to keep yourself in good health also during the winter.


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MarianaNamoradoTechnical-Scientific Department, LABIALFARMA, S.A.

The Complementary Feeding-stuffs (CFS) have a crucial impact nowadays, since they intend to complement the nutritional needs of animal, not supplied by their standard diet. Thus, they are an important help in growth and development of animals. In this context, it is important to speak ofCFS’s importance in animals, as a“help”to fight osteoarticular problems. The most common form is Osteoarthritis: acondition that is characterized by the degeneration of articular cartilage and the formation of small portions of bone that lead to surface roughness in the joint and pain, although lesions caused by osteoarthritis in the joint structure may exist before the appearance ofthesesymptoms.Manifestationof thesesymptoms can occur in one or more joints, but more oftenly at the knees, the hips, shoulders and elbows. In the case of osteoarthritis, problems result from excessive wear or from lesions the atthe cartilage level. Cartilage functions as a shock absorber that protects the underlying bone and involves the joint.

Nutrients such as chondroitin sulfate and glucosamine protects cartilage against possible injuries and increase chance of recovery.

Glucosamine (2-amino-2-deoxy-D-glu-cose) is a natural amino saccharide syn-thesized from glutamine amino acid and glucose. It is present in meat, fish and in almost all tissues, being found especially in cartilaginous tissue (James et al. 2001). It is also present in chitin, main compo-nentoftheexoskeletonofcrabsandoys-ters, among other crustaceans.

It is a key component for the joint struc-ture,andoftenconsideredthe“buildingblock” of the extracellular cartilagema-trix.Glucosamineissynthesizedbychon-drocytes (cartilage cells) from glutamine and Glucose, embodied in the form of

N-acetylglucosamine, in the polysac-charide chains of glycosaminoglycans. Glycosaminoglycans are precursors ofproteoglycans, main structural constitu-entsofarticularcartilagematrixandgivethem the strengthandflexibilityneces-sary for locomotion.Furthermore,glucosamine is a constitu-ent of hyaluronic acid, an important con-stituent of the synovial fluid, a viscous fluid present in the joint cavities, that lubricates and exerts trophic effects onjoint cartilage. Being an essential pre-cursor molecule in the synthesis of gly-cosaminoglycans and hyaluronic acid, glucosamine has an important role in the formation and maintenance of con-nective tissue and joint cartilage lubricat-ing fluid, preventing the degeneration of articular cartilage that occurs during and aging process and osteoarticular disease.

Natur.Vet Pet Care NutritionComplementary feeding stuffs (CFS) for your pets

DID YOU KNOW…

The use of CFS in pet may module some inflamatory processes related to osteoarthritis, thus favoring cartilage repair and protection against joint degeneration.


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The exogenous glucosaminesupplementation replaces any endogenous deficiency of this substance, allowing its use as a substrate by chondrocytes, contributing to the structure and function of the cartilage. Glucosamine,especiallyintheformofthesulfate salt thus appears to be essential

for the formation and maintenance of a healthyjointmatrix,whichcanslowdownor reverse the degeneration of articular processes of osteoarthritis. We conclude that glucosamine stimulates the synthesis of substances that are part of the cartilage - glycosaminoglycans (GAGs) - andstimulates the renewal of the cartilage

� On June 14th was published the first review of the medicine’s list subject toadditionalmonitoring in the context ofpharmacovigilance.

� Japan and the United States joinSwitzerland and Australia on the list ofcountries of the European Commission with quality requirements for active substancesequivalenttotheEU,ensuringthe same level of public health protection.

� A Canadian study of the Cochrane Review with over 4000 individualscorroborated the prescription, as widely reported in clinical practice, which is the association of probiotics administration to antibiotics for the prevention of diarrhea. This association showed a reduction of 64% in thenumber of people with diarrhea caused by Clostridium difficile.

� Data were released from the VITAL study (one cohort with 75.137 people), about the effects of glucosamine and chondroitin supplements for colon cancer. This supplementation was shown to reduce the risk of disease, despite some differences recorded according to body mass index andfrequency of dosing. This association had been linked before to a decreased risk of lung cancer and total mortality, also according to theVITAL -VITaminsAndLifestyle.

� Fish oil supplements, the well-known omega-3 fatty acids capsules, may have benefits in the therapeutic approach of type II diabetes, according to the Journal of Clinical Endocrinology & Metabolism. A recent reviewof 14 clinical trials, fromthe Harvard School of Public Health,

confirmed that these supplements increase the amount of circulating adiponectin. This hormone is associated with various metabolic processes and the glucose management.

� The Observatory of Plant-Drug Interactions of the Faculty ofPharmacy, University of Coimbra willbe the national body responsible for the receipt and sending of reports with adverse effects caused by natural origin products to the respective authorities, depending on whether is a food supplement, a food or a medicine.

� Vitamin Cmay reduce theexercise-induced bronchoconstriction by 48% (versus placebo) reveals ameta-analysis from theUniversity ofHelsinki, recently published in the BMJOpen.

� The electronic edition of the journal Annals of Internal Medicine published a study carried out by academics from the Universities of Harvard andWashington, in which was shown that individuals over 65 who have high levels of omega-3 in the blood, live in average additional 2,2 years. This outcome shall be due to the recognized positive impact that these fatty acids have on cardiovascular health.

� Belgium has a new online platform(FOODSUP) for electronic notification of food supplements and fortified foods to the authority of this country (SPF Santé Publique). However, this does not exempt the compilationof a dossier for marketing nor its regulatory approval for marketing in Belgium.

SHORT NEWS� There is an ongoing project to a

new positive list of plants shared by Belgium, France and Italy - BELFRIT- for use in food supplements. The regulatory authorities of these three countries have a similar understanding on this matter and decided to join forces to simplify trade and facilitate the application of the principle of mutual recognition. This is a serious work, conducted by renowned European experts, whoprovide solid instructions about the quality and safety in the selection and control of botanical ingredients. Another good new is the inclusionof data on traditional use as part of the scientific evidence to consider. Germany has also expressed itssupport and interest in this project, which gives a hope in the so dreamed European harmonization in FoodSupplements.

� The benefits of probiotics are well known on the intestine but now it is suggested that probiotics may also play a role in the modulation of pain sensitivity, stress response, mood or anxiety. These are data from theUniversity of California, publishedin the journal Gastroenterologyand based on clinical experienceobtained with the bacterial strains: Bifidobacterium animalis, Streptococcus thermophiles, Lactobacillus bulgaricus and Lactococcus lactis.

� A review published in the Journal of Lipid Research found that there are mechanisms for preventing excess supply of vitamin E in the liver. This review contradicts popular theories which claim that eating too much vitamin E would be harmful to the body.

(favoring, in particular, the synthesis of collagen - constituent of cartilage fibers).

References:

James CB, Uhl TL., A review of articular cartilage

pathology and the use of glucosamine sulfate, J

AthlTrain.2001Oct;36(4):413-9.


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The continued presence of GROUPLABIALFARMA companies in this eventhas proven crucial for the promotion of our products and services in the international market.

The GROUP LABIALFARMA achievessuccess internationally and in particular inthisexpositionbecauseeffectivelyhasbeen offering to its customers what they seek the most in this event, as you can see by the given picture which makes the characterization of the visitors and what the areas of greatest interest are.

The available data easily demonstrate that LABIALFARMA GROUP is clearly

a potential business partner for any visitor at VITAFOODS and justifies somehow why our stands are two of the most visited one of the whole event.

Over the period offive years in which we have partici-pated in interna-tional expositions,the GROUP LABIAL-FARMA establishedmore than 1300 con-tacts(seechart“NewContacts”) amongcompanies around theworld.Thisexpe-rience allows us to address any market safely and confident-ly, responding to all quality & regulatory requirements of des-tination markets.

Over the years, withthe establishment of trade relations with more and more in-ternational partners, the participation in this kind of events

The GROUP LABIALFARMAattended once again the international event VITAFOODS in Geneva.

The VITAFOODS EUROPE took place on the 14, 15 and 16 of May 2013. The strong presence was evident by the stands of two of the Group companies, LIQFILLCAPS International and WELLCARE.


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became truly essential. We continue to promote the growth of new contacts but we are especially dedicated to turning ourpresence ina“giantmeeting room”,so we can meet face to face with our long lasting and brand new customers and partners. Each year the total number ofpre-scheduledmeetingsincreases.Forexample, this year the participation oftheGROUPLABIALFARMAatVITAFOODS2013 generated more than 50 meetings (previously scheduled) between our sales team and international companies from various parts of the globe.

We are already preparing the CPhI 2013*! We look forward to your visit!

* www.cphi.com | 22-24October 2013| Frankfurt – Germany | LIQFILLCAPSInternationalBooth42G20.

New contacts


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The first goal of a company is its economic survival, in other words, its profitability. The great discovery of this globalized time is that everything is connected. It is in the interest of companies to ensure the sustainability of systems and subsystems of the community where they are inserted. The support and defense of populations and local values imposes itself as a means of guaranteeing social peace that depends on the prosperity of companies.

The culture of “think globally, actlocally” has always been a reality forLABIALFARMA SA (founded in 1981).The placement in the company of employees living in the community, taking advantage of local resources, is a principle of responsible and sustainable management creating value in the local community, thus reducing the socio-economic disparities in the region.

In this “Think Global...” con-cept, LABIALFARMA SA hasdecidedtoextenditssocialresponsibility and embrace

a project called “Beautiful Work”in partnership withADRA(Non-Government Or-ganization).

In this project, LABIALFARMA SAhas manufactured pharmaceutical products, with volunteer work of its employees in the production and packaging of these products.

The wish of Labialfarma Group is to create a smile on every child.

LABIALFARMA DAY

To strengthen their culture “... Act locally “the GrupoLabialfarma has promoted, once again, a social event. PerformingaPopularFestivalwith the collaboration of the

Beautiful Work

Association of Felgueira, attended byall employees in perfect harmony and friendship with the goal of raising funds to support the purchase of a wheelchair adapted to special needs education of theMadalena,6yearsold,carrierofwithnon-ketotic hyperglycinemia, embracing, thisway,theproject“ToGrowinsolidarity”developed by the Group of schools ofMortágua. Itwas thefirsteditionof the“LABIALFARMA day”, an event to bescheduled for the future, on the third SaturdayofJune.

NUMBERS:

200 M€The Portuguese market of food supplements worth around 200 M €, employing 10,000 people in Portugal (according to data from 2010).

22%Market share of food supplements within the products sold in pharmacies, excluding medicines.

2018Expected year for EFSA provide its evaluation about the data collection regarding foodstuff consumption in the European Union, which is now taking place – EU Menu Project.

30%The equivalent of 22 million overweight or obese children in the member states of the EU.

50 000It is the number of additional users who can benefit from dental checks, with the recent decision to increase the age limit for young people up to 15. This oral health program is a partnership involving the Order of Dentists and the Ministry of Health.

124Amount of cancer medications that have entered the market over the past 30 years. Of these, only 20 are from chemical synthesis. All the rest are of natural origin.

GoretiPrataHuman Resources DepartmentLABIALFARMA, S.A.


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Organic Teas – A line of solutionsWELLCARE® PHARMAWelcome to Wellcare, a world of healthy & flavoured sensations!

Wellcare teas & infusions,isoneofthecompaniesbelongingtotheLABIALFARMAGroup,capableofoffering

a whole series of fundamental conditions (adjustment of batches, innovative presentations, technical support,

research and development) for the manufacture of teas and infusions of ideal quality.

Joining the wisdom of those who know, evaluate and perfect the best plants of selected origins to the pharmaceutical

knowledge of the multiple benefits for the health and the well-being, we obtained a selection of premium raw

materialsofexcellentqualityassembledinthe Wellcare Teas & Infusions.

ThatwasthechallengeacceptedbyagroupofbiologistsandpharmacistsofLABIALFARMA,expertconnoisseurs

and tasters of this ancient drink, creating a variety of teas and infusions that differ in aroma, in flavor and in the

benefits that comfort body and spirit.

Wellcare is certificated with organic production mode, allowing the possibility of presenting

finish organic teas and infusions.

The Organic “BIO” range of Teas

Perfectfunctional,best-tastingteasandinfusions,foractiveandhealth-consciouslifestylesoftoday’sgeneration.:

• BIOAntioxidantwithGoji;

• BIODigestion;

• BIOWinter;

• BIOStress;

• BIOConstipation;

• BIOUrinarySystem;

• BIOBlack+GreenTea;

• CháGreenMintTea;

• BIODesmodiumPlant(Hepatoprotection).

PT–BIO-03


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During Winter, we are commonly affected by several adverse situations that weaken our immune system, favoring the onset of various diseases, especially of the respiratory tract, such cold, cough, stuffy nose and sneezing. Since most of thesediseases are viral, the use of antibiotics becomes ineffective, for which reason the prevention and stimulation of immune system plays an important role in order to promote health and well-being of the population.Besidesthiskindofsymptoms,many people tend to suffer more of osteoarticular discomfort at this time of the year. Vitamins and minerals, as well as some plants may be useful for the prevention and treatment of such symptoms.

Vitamin C has been used for many years to help prevent or treat colds. Several studies have been performedto determine what dose should be considered for preventing colds and associated symptoms. However, high doses of vitamin C for longer periods of time may also cause diarrhea and nausea, especially in children. Thus, the ideal dose should not exceed 200mg/day. According to the new Regulation,the food supplements containing at least 15%oftheRDA(12mg)mayclaimthat:

- Vitamin C contributes to the normal function of the immune system.

- Vitamin C contributes to the protection ofcellsfromoxidativestress.

- Vitamin C contributes to the reduction of tiredness and fatigue.

Regarding of the osteoarticular diseases, vitamin C can slow the worsening of the symptoms associated with these diseases. Thus, the vitamin C obtained by diet and/or supplementation can prevent cartilage loss and the aggravation of the symptoms of the osteoarthritis disease. In the same way, we can apply the following approved health claims for this vitamin:

- Vitamin C contributes to normal collagen formation for the normal function of bones.

- Vitamin C contributes to normal collagen formation for the normal function of cartilage.

Zinc is also used to stimulate the immune system, for treatment and prevention of infections of the lower respiratory tract, as well as in the repair of affected tissues. However, the evidence of its effectiveness has been mixed and many study areinconclusive regarding the action mechanism and it is not recommended the intake of a high dose of zinc for more than 5 days. Knowing so, that the approved health claims for this mineral are:

- Zinc contributes to the normal function of the immune system.

- Zinc contributes to the protection of cellsfromoxidativestress.

We can predict that, with at least 1,5 mg of Zinc, we can achieve a beneficial effect to the main symptoms caused by weakness of the immune system.

Regarding the use of plants, Echinacea may be useful for the prevention and treatment of colds in short term. It is also used to stimulate the immune system in general.

Be active, in this WinterAnaTelesTechnical-Scientific Department,LABIALFARMA, S.A.

Due to this immunostimulant activity, this botanical is contraindicated in people with autoimmune, immunosuppressive and immunodeficient diseases and those affecting the production of white blood cells. ManystudieshavebeendoneontheuseofEchinacea in treating colds, but the results have been mixed. Those who attribute apositive effect, show that this plant should be taken in the earlier stage of colds.

Startingfromtheseassumptions,abalanceddiet and a proper supplementation can minimize the problems caused during the coldest season of the year, offering a better quality of life.

References:

- American Botanical Council, 6200 Manor Rd, Austin, TX 78723

- Final Community Herbal Monograph on Echinacea purpurea (L.) Moench – Committee on Herbal Medicinal Products (HMPC) – 8 May 2008

- Health Line – By Tara Gidus, MS, RD, CSSD, LD/N | Published 19/Set/2008 http://www.healthline.com/health-blogs/diet-diva/feeling-cold-coming

- National Institute of Allergy and Infectious Diseases – Common Cold - April 13, 2011 -http://www.niaid.nih.gov/topics/commoncold/pages/prevention.aspx

www.Webmed.com


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There are several products in the European Economic Area that can onlybe commercialized if bearing the CE mark.Afewexamples:pyrotechnics,toys,gas appliances, elevators, measuring instruments and construction materials. And what exactly does this CE mark? It’s the way manufacturers have tocommunicate to consumers/users and authorities that their products meet all applicable legal provisions (requirements of health, safety, hygiene, protection).

The huge group of articles included in medical devices category is also under this regulation. And the higher the riskinvolved in their use, higher the level of demand when assessing the compliance with the respective European Directives. Such a way that, for various casesprovided by the legislation, it will be necessary to rely on a certification by a third party, empowered to that effect by the relevant European authorities, so that the product can be placed on the market and can freely circulate within the EEA. This entity is called the Notified Body and is also, itself, subject to a rigorous competence assessment by the member state authority who named it. Nevertheless,theNBissupervised by the European Commission as well. Currently, there are 77 listed companies across Europe to perform this service, whether they are public, private or semi-private.

Portugal, until quite recently, also hadan entity that ensured this certification – INFARMED, I.P. – integrated theState administration and it was a greatsupport to national manufacturers of the sector. For years, it contributed tothe introduction of novel and valuable products to market, with inherent benefits for public health.

Unfortunately, our country faces toughtimes in which austerity prevails and

the increasing community demands for regulatory evaluation of medical device ended up to be fatal to the NotifiedBody: itwasnecessarymore investment to keep up the service and the Government simplycould not stand such expense… Anyway,the final extinction is now announced for the 30th of September of this year and there is no turning back.

The question now arising is:WHAT ’S NEXT? WHAT SOLUTIONS ARE LEFT FOR PORTUGUESE MANUFACTURERS?

During this period before the stipulated deadline, manufacturers must look for a new Notified Body if they want to continue trading their devices. Despite the high number mentioned above, the truth is that there is no other agency headquartered in Portugal. So, thisimplies a significant increase of the expenses, in particular with translationand audit costs (auditors travels, lodging and accommodation costs), not to mention the higher fees charged abroad...

Given this scenario, the Portugueseeconomic operators will inevitably face more difficulties in accessing the supply chain, from the very first design of their

The End of the Portuguese Notified Body (INFARMED-ON)Certified Medical Devices: what happens now?

Ricardo DeusProject Manager / Regulatory Affairs, NUTRI.ADD, S.A.

new products, till the assignment of the indispensable CE Certificate of ConformitybytheresponsibleNB.

Regardless of the obstacles that this cessation causes, the manufacturers up to this challenge will certainly be before the chance to earn higher international dimension, interacting directly with established organisms in key markets, well-connected and holders of a solid reputation that will surely be extendedto certified products.

LABIALFARMA has good institutional relations and maintains contacts with several Notified Bodies spread across the European Union, which are ready to assume any process of conformity assessment for new pharmaceutical developments, fitting into the group of medical devices we manufacture.

DID YOU KNOW...

Notified Bodies can evaluate the compliance of medical devices through: revisions of the technical documentation by experts, usability testing, laboratory analysis, inspections to the manufacturer’s facilities or even require for clinical trials!


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smartPACKAGING is a set of unique and invariably innovative solutions for primary and secondary

packaging that has been designed, developed and implemented by LABIALFARMA, SA.

smartPACKAGING - intelligent packaging for innovative products!

FUSiONPACK® is the innovative solution

that fuses in the same blister, liquid and solid

pharmaceutical forms.

With FUSiONPACK® an ampoule with a

capsule or tablet can be combined in a single

blister.Thisprovidesmaximumstabilityforthe

active ingredients, in optimal concentrations,

in an intelligent, modern and attractive

package that makes the product more

convenient to use and easier to transport.


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HIGHER ACTIVE STABILITY • Avoidsincompatibilitiesbetweeningredients(Hydro/Liposolubleactiveseparation)

• Highersolubility

• Usageoflightproofmaterials

• IdealpH

DOSAGE OPTIMIZATION • Highereffectivenessoftheproduct

• PossibilityofincludingHealthclaims

• TASTE|TEXTURE|NICERODOR

• Highertherapeuticadherence(Valerian,Mgsalts,Fishoils)

PORTABILITY • Portable–higherresistanceandeasilycarriedanywhere.

• Convenient - theFUSiONPACK® ampoule opens very easily and the aluminium base

peels off.

Example: The FUSiONPACK® it’smuchmore practical than their simple separately forms of

presentation(capsuleortablet+ampoule)

PAST ▶ PRESENT ▶

We studied the PAST,Evaluate the PRESENT,

Created the FUSiONPACK®


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The VIGIA system is a backup service for consumers and health professionals, that aims to clarify doubts regarding the intake of dietary supplements and teas. These are some examples of questionsthat arise in everyday use and to which we try to answer the best way possible, so that the consumer is fully informed about the product that will be taking and what are the implications for his organ function and / or it’s state of health, as

well as in relation to the simultaneous use with other products and medical drugs and, thereby, expresses thepracticaluseoftheVIGIAservice for its users.

FAQ’s:

“CanItakethefoodsupplement X, whentaking medication that the doctor prescribed tome?”

“Istartedtakingthesupplement X 2 daysago. I got headaches. Is it due to taking the product?”

“Howshould Iusethisproduct?”

“Iamverysatisfiedwith the product. Can I take another package?OrshouldIstophere?”

“IhavebeendiagnosedthediseaseY.CanItakesupplementXsafely?”

“If you take half the recommendeddose,willIgetthesameeffect?”

“I’m on the pill as a contraceptivemethod, can take the same SupplementXwithoutthepilltoloseit’seffect?”

The last decade has witnessed a boom in the consumption of food supplements and nutraceutical products composed of bioactive agents and natural substances such as vitamins, minerals, amino acids, essential fatty acids, plants and derivatives, etc.. These products play an important role in the health care systems, as they allow consumers to supplement their normal diet. They provide a nutritional and physiological effect, and thus contribute to maintaining good health.

Today, the importance and role of food supplements in human health and well-being is indisputable.

As food supplements, nutraceuticalproducts and infusions are consumed to obtain a positive effect on health, it is easily understandable that their components physiologically and / or metabolically act in the body, which can convey health benefits and / or even adverse events, in a few rare cases.

MOBILE PLATFORM- FEATURESVersion 2.0 of VIGIA enables you, via your mobile telefone to:

VIGIA System

Obtain information on the VI-GIAsystem;Obtain contacts to commu-nicate directly with a health professional;Photograph the QR code ofthe Packaging and obtain thefollowing information about productsintheVIGIAsystem;Productname;3D image;Composition;Instructions for use;Safety;

How to take the product;Geographical location of sell-ing points with the possibility ofconnectingtoGPS;Suggestedrelatedproducts;Search for information onproducts by name, instructions for use, brand and/or composi-tion;Obtain useful health informa-tion on: reference levels of cholesterol, triglycerides, blood pressure, blood glucose, body massíndex,etc.

VIGIA is good to your health

Vigilancefor Food Supplements


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The quality control in food supplements should be understood as the set of analyzes performed during production, processing, storage and marketing of the product in order to maintain quality in adequate levels of acceptance. This control requires a specification or set of specifications that must be met inconformity with acceptance limits. The food supplement quality is therefore defined by the evaluation of various parameters in the different production phases. Thus the beginning of this control occurs at the level of raw materials upon receipt. Gauging the quality of theseraw materials is done using a battery of analyzes ranging from its physical-chemical control, which include tests for identification and organoleptic characteristics, to the microbiological analyses.

During the process of food supplements manufacture,theDepartmentofQualityControl is responsible for the In process

control from which results intermediate products.At this stageand inagenericway, the specifications are set according

to the final product presentation, as it is before syrups, gels, tablets, capsules, soft / hard, suppositories, capsules, etc.

As regards control of the final product,this involves, again, the use of microbiological and analytical methods which are defined specifically for each food supplement. Just before the results of this final inspection, it can be decided about the conformity of the product and thus allow its approval to market release.

Indeed,theQualityControlLaboratoryofLABIALFARMAreferstomethodsofhighprecision – HPLC – High PerformanceLiquid Chromatography, GC (Gas

Chromatography) or spectrophotometric methods,suchasInfraredandUltraVioletspectrophotometry.

This lab is composed of a high qualified team. Experienced analysts, that arepermanently trained, are daily working toensuretheaimofthiscontrol–ahighlevel of quality in the food supplements.

Thus, the department of Quality controlplays an invaluable role in supervision of all production phases, detecting or minimizing potential failures in the course of the same. This department has not only a corrective but also a preventive action.

The Quality Control in Food Supplements is, nowadays, as in the future, a premise that aims to satisfy the final consumer that is increasingly demanding, in a market that is becoming more and more competitive.

The quality at LABIALFARMA GROUP is,therefore, more than one requirement, a demand.

Food SupplementsQuality Control always present at LABIALFARMA S.A.MarianaCostaQuality Control DepartmentLABIALFARMA, S.A.

NUMBERS:

1000 M€was the approximate value for the Portuguese exports in the health sector in 2012, including pharmaceutical products, pharmaceutical preparations, medical-surgical material and instruments, as well as irradiation, electromedical and electrotherapeutic equipment.

1/3The WHO website indicates that a third of cancers can be prevented and points out the poor eating habits as a factor to modify.

SOME OFFICIAL DATA OF THE ANNUAL REPORT OF THE FAO (June/2013):

12,5% 26%

Of the world population is undernourished. Is the estimate of children who are underweight worldwide.

2.000 Milhões 1,4 mil milhõesNumber of people who suffer from deficiencies in one or more micronutrients. Number of overweight people. 500 million of whom are obese.


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REGULATORY CALENDAR

Take note:

1 June 2013Entry into force of the Union list of food additives established byCommission Regulation (EU) No 1129/2011 of 11 November 2011amendingAnnexIItoRegulation(EC)No1333/2008.

14 June 2013Deadline according with DGAV order (Despacho nº 13788/2012) for disposal ofstocks of food products marketed in Portugal that do not comply with CommissionRegulation(EU)No432/2012of16May2012establishingalistofpermittedhealthclaimsmadeonfoods,otherthanthosereferringtothereductionofdiseaseriskandtochildren’sdevelopmentand health.

2 July 2013ImplementationofnewrulesforimportofactivesubstancestotheEuropeanUnion,according“falsifiedmedicinalproductsDirective”– Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on theCommunity code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.

11 July 2013DateofimplementationoftheRegulation(EC)No1223/2009oftheEuropeanParliamentandoftheCouncilof30November2009oncosmeticproductsandrepealingDirective76/768/EEC.

19 July 2013Applicationofarticles11,16,18and19ofrecentRegulation(EU)No609/2013oftheEuropeanParliamentandoftheCouncilof12June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control.

4 August 2013Implementationofthe“RegulationofVariations”–CommissionRegulation(EU)No712/2012of3August2012–Concerningtotheterms of marketing authorisations submitted by national procedure.

1 September 2013MarksthedaythatwillputintopracticetheCommissionImplementingRegulation(EU)No198/2013of7March2013ontheselectionof a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring.

1 September 2013EntryintoforceoftheRegulation(EU)No528/2012oftheEuropeanParliamentandoftheCouncilof22May2012concerningthemakingavailableonthemarketanduseofbiocidalproductsandrepealingDirective98/8/EC.

THERMOMETER

• The new regulation for the cosmetic and personalcare products is about to enter into force. Are you ready?

• Increaseinthepopularityofgreencoffeeextract!Willbe the next commercial success?

• Sixnewgeneralallowedhealthclaimsinfoodstuff!

• Benefits of red fruits (cranberries) increasinglysubstantiated.

• Relevance of the NIH report about the toxicity ofGinkgo biloba extract.

• Uncertainty in the available evidence about therelationship between beta-carotene and smoking.

• PIP breast implants scandal in court. The sentencewill be announced in December.

• Resistance to antibiotics more worrying than ever,according to a U.S. study published in the Nature.


17

LABIALFARMA GROUP marked its presence at…

� Low vitamin D serum concentration is associated with high levels of hepatitis B virus (HBV) replication, article of theHepatology journal. Vitamin D could improve disease control in people with asthma, reducing hyper-immune responses that inflame the airways. The study was carried out by researchers fromUKandthestudywaspublishedinthepeer-reviewedJournalofAllergyandClinical Immunology. Results suggest the possibility of reducing the amount of steroid-based medicines prescribed or even treat asthma with the sunshine vitamin. We look forward to the results of further research.

� AresearchoftheUniversityofAdelaideshows the most comprehensive analysis of the effect of garlic (Allium sativa) on cholesterol. The study analysed results from 39 separate trials, the parameters tested were: total cholesterol, LDL, HDL and triglycerides.

The study concluded that the consumption of garlic supplements, every day for more than two months, can reduce 38 per cent in risk ofcoronary events at 50 years of age.

SHORT NEWS� Portugal and Saudi Arabia recently

signed a cooperation agreement in nine areas of the health sector, including the pharmaceutical sector.

� APORMED with new administration for themandateof2013-2014.Thepresidentof the national association of companies operating in the medical devices sector is now Dr. Antonieta Lucas.

›› NUTRI.ADD participated with two oral communications at the Technical Conferences «The Natural Compounds in the Food Industry», applicabletoproductsofplantorigin(Dr.JoséMalta)andapplicableto products of animal origin (Dr. DianaMachado).The event tookplaceonMay15atBiocantPark inCantanhedeandonMay29atTagusValley in Abrantes.The NUTRI.ADD presentations addressed the topic “How to make the product nutraceutical or functional - Regulatory Framework.”

›› It took place in the past 18 and 19 of April, the XIII International

Congress of Costs - Cost Management, a path in times of crisis, at the CustomsBuildingofOporto, in thecityofOporto,promotedby IIC- International Institute of Costs and theOTOC -Order of Chartered

Accountants,where itwaspresentedacommunicationbyDr.PedroCarvalho, from GESCONSULTING, entitled Strategy, Going Concern

and Z-Score.

On the 9th ofMay, the day of theMunicipality ofMortágua, LABIALFARMA was awarded with the Gold Medal of Merit in Municipal solemn session held at theCulturalCentreofMortágua.Dr.PedroCarvalhofromGESCONSULTING honorably represented the company.

››


18

EVENTS

1-12 JULYInternational Summer School on Principles – Oriented Systems BiologyBiocant Park, Cantanhede.

19 JULY1st International Meeting on Stem Cells for Regenerative Medicine and Drug ScreeningBiocant Park, Cantanhede.

31 AUGUST-5 SEPTEMBERFIP World Congress 2013:“Towards a future vision for complex patients”Dublin, Ireland.

4 SEPTEMBERWorld Sexual Health Dayhttp://www.worldsexology.org/

11-13 SEPTEMBER3rd Annual Pharma eMarketing CongressBarcelona, Spain.

29 SEPTEMBERWorld Heart Dayhttp://www.world-heart-federation.org/what-we-do/awareness/world-heart-day/

22-24 OCTOBERParticipation of LABIALFARMA Group in CPHI/CSE 2013 | Frankfurt, Germany.LIQFILLCAPS International – Stand 42G20http://www.cphi.com

25-26 OCTOBERXXVIII 2013 Series of the Portuguese Association of General and Family Medicine of the Delegation of Coimbra DistrictBiocant Park, Cantanhede.

6-8 MAY 2014Participation of LABIALFARMA Group in Vitafoods 2014 | Palexpo Genebra, Switzerland.LIQFILLCAPS International – Stand 18037http://www.vitafoods.eu.com

FACTS OF PUBLICATION | ENGLISH VERSION

Property: LABIALFARMAGroup

Editorial board:A.Ferraz(President),DanielaFerraz(GeneralCoordinator),JoséMalta(GeneralandOperationalManager),RicardoDeus(OperationalAssistantManager), Jorge Serra, Pedro Carvalho, Pedro Laranjo, Goreti Prata, MarianaNamorado, Rui Cruz, Helton Santos, Cláudia Barroso, André Neves, MarianaCosta, Joel Rocha.

Periodicity:Quarterly

Free distribution

LABIALFARMA Group | EdifícioLABIALFARMA,1|Felgueira

3450-336Sobral,Mortágua|Portugal

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